MAUDE Adverse Event Report: CONVATEC INC FLEXI-SEAL PROTECT; POUCH, COLOSTOMY

Model Number 421630

Device Problem Off-Label Use (1494)

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

Affiliation: (b)(6) hospital.Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Should additional information become available, a follow-up report will be submitted.Fda registration number, reporting site: 1049092, manufacturing site: 8022978.

Event Description

It was reported "no pr exam prior to insertion of fms; patient was restless so the device was removed after only 7 hours in situ.After 21 days post removal, the patient was noted to be admitted with circumferential rectal necrosis, subsequently requiring to have a permanent colostomy.".

• Brand Name: FLEXI-SEAL PROTECT
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 17181572
• MDR Text Key: 317648142
• Report Number: 1049092-2023-00179
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455143016
• UDI-Public: 768455143016
• Combination Product (y/n): N
• PMA/PMN Number: K162906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 421630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1