Intrauterine Tamponade Balloon Complications in MAUDE Database a Critical Analysis
Author(s)
Ajoshson John, PharmD1, Deeksha S, PharmD2, Adusumilli Pramod Kumar, Ph.D3, JEESA GEORGE, M Pharm3.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bengaluru, India, 3M S Ramaiah University Of Applied Sciences, Bangalore, India.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bengaluru, India, 3M S Ramaiah University Of Applied Sciences, Bangalore, India.
OBJECTIVES: Intrauterine tamponade balloons (IUTBs) are employed in the management of postpartum hemorrhage (PPH), particularly in cases of uterine atony, to reduce the need for surgical interventions such as hysterectomy or uterine artery embolization. However, their use may be associated with adverse outcomes. This study aims to evaluate adverse events related to IUTBs reported in the MAUDE (Manufacturer and User Facility Device Experience) database, focusing on device malfunctions, patient complications, and manufacturer involvement.
METHODS: A retrospective review was conducted using MAUDE database entries from January 1, 2020, to November 25, 2024. Reports referencing IUTBs were identified, extracted, and categorized according to device issues, patient-related complications, manufacturer data, and device classification codes. Descriptive statistics were used to summarize reporting trends and outcomes.
RESULTS: A total of 901 adverse event reports involving IUTBs were identified. Device malfunctions constituted over half the cases (507/901). The most frequently reported device issue was “Adverse Event Without Identified Device or Use Problem” (400/901). The most commonly reported patient-related outcome was “No Clinical Signs, Symptoms, or Conditions” (306/901). COOK INC was identified as the manufacturer in 419 reports. The device code K170622 was cited in 400 cases. Affected anatomical areas included the uterus, cervix, and vagina.
CONCLUSIONS: Adverse event data suggest that while IUTBs are a valuable tool in the management of PPH, complications related to device malfunction and inconsistent patient outcomes warrant further attention. Limitations such as potential underreporting and incomplete entries reduce the granularity of MAUDE data; however, it remains a crucial source for post-market surveillance. Improved device training and reporting practices are essential to ensure safe and effective use of IUTBs.
METHODS: A retrospective review was conducted using MAUDE database entries from January 1, 2020, to November 25, 2024. Reports referencing IUTBs were identified, extracted, and categorized according to device issues, patient-related complications, manufacturer data, and device classification codes. Descriptive statistics were used to summarize reporting trends and outcomes.
RESULTS: A total of 901 adverse event reports involving IUTBs were identified. Device malfunctions constituted over half the cases (507/901). The most frequently reported device issue was “Adverse Event Without Identified Device or Use Problem” (400/901). The most commonly reported patient-related outcome was “No Clinical Signs, Symptoms, or Conditions” (306/901). COOK INC was identified as the manufacturer in 419 reports. The device code K170622 was cited in 400 cases. Affected anatomical areas included the uterus, cervix, and vagina.
CONCLUSIONS: Adverse event data suggest that while IUTBs are a valuable tool in the management of PPH, complications related to device malfunction and inconsistent patient outcomes warrant further attention. Limitations such as potential underreporting and incomplete entries reduce the granularity of MAUDE data; however, it remains a crucial source for post-market surveillance. Improved device training and reporting practices are essential to ensure safe and effective use of IUTBs.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD111
Topic
Clinical Outcomes, Epidemiology & Public Health, Real World Data & Information Systems
Disease
Injury & Trauma, No Additional Disease & Conditions/Specialized Treatment Areas, Reproductive & Sexual Health, Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)