MAUDE Adverse Event Report: CONVATEC INC FLEXI-SEAL PROTECT PLUS; Tubes, gastrointestinal (and accessories)

Model Number 421703

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Common device name: tubes, gastrointestinal (and accessories).Affiliation: (b)(4).Based on the available information, this event is deemed to be a serious injury.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.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported patient exhibited a "full thickness wound, injury is adherent slouch covered.Injury is to the perirectal skin just inferior to the rectum." it was further stated the bag is usually at the end of the bed.The device was in place from april 1 to april 5.The device has been removed.

• Brand Name: FLEXI-SEAL PROTECT PLUS
• Type of Device: Tubes, gastrointestinal (and accessories)
• 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: 16760737
• MDR Text Key: 313486256
• Report Number: 1049092-2023-00049
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00768455145836
• UDI-Public: 00768455145836
• Combination Product (y/n): N
• PMA/PMN Number: K190114
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 421703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2023
• 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: Unknown
• Patient Sequence Number: 1