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

Model Number	421703
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1049092-2023-00049
• Device Sequence Number: 17668591
• Product Code: KNT
• UDI-Device Identifier: 00768455145836
• UDI-Public: 00768455145836
• Combination Product (Y/N): N
• Initial Reporter State: IN
• PMA/510(K) Number: K190114
• 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): 04/07/2023

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: 421703
• 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: 04/07/2023
• Initial Report FDA Received Date: 04/18/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown