MAUDE Adverse Event Report: COOK INC. CERVICAL RIPENING BALLOON; DILATOR, CERVICAL, HYGROSCOPIC-LAMINARIA

Lot Number 14516760

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2022

Event Type  malfunction  

Event Description

Provider placed cervical ripening cook balloon.Approximately 1830 provider was called to room to evaluate leaking of fluid.Upon further investigation, provider discovered that vaginal balloon had ruptured.Balloon was not replaced.Fda safety report id# (b)(4).

• Brand Name: CERVICAL RIPENING BALLOON
• Type of Device: DILATOR, CERVICAL, HYGROSCOPIC-LAMINARIA
• Manufacturer (Section D): COOK INC.; bloomington IN 47404
• MDR Report Key: 15412598
• MDR Text Key: 299866576
• Report Number: MW5111983
• Device Sequence Number: 1
• Product Code: HDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 14516760
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female