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

Catalog Number G19891

Device Problem Material Rupture (1546)

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

Event Date 02/16/2021

Event Type  malfunction  

Event Description

Cnm placed cook cervical ripening balloon.Once placed, uterine balloon was filled up with 80 cc's (within limits for product).Shortly after filling balloon, it "popped" inside patients uterus.A 2nd crb placed successfully.Fda safety report id # (b)(4).

• Brand Name: COOK CERVICAL RIPENING BALLOON
• Type of Device: DILATOR, CERVICAL, HYGROSCOPIC-LAMINARIA
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 11357961
• MDR Text Key: 233138598
• Report Number: MW5099514
• Device Sequence Number: 1
• Product Code: HDY
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G19891
• Device Lot Number: 13497655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 115