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

Model Number	421630
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Necrosis (1971)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1049092-2023-00179
• Device Sequence Number: 6391996
• Product Code: EZQ
• UDI-Device Identifier: 00768455143016
• UDI-Public: 768455143016
• Combination Product (Y/N): N
• Initial Reporter State: WA
• PMA/510(K) Number: K162906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown