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

Model Number	421630
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
Event or Problem Description
It was reported the patient had a full thickness pressure injury when using the fecal management device (fms).Fms was in place (b)(6) 2022.It was unknown if a rectal exam was done prior to placement and unknown how much fluid was instilled in the device.Medical treatment was provided however type of medical treatment was not provided.The fms device was discontinued.Patient was discharged from the hospital.

• Brand Name: FLEXI-SEAL PROTECT
• 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: 16910821
• Report Number: 1049092-2023-00153
• Device Sequence Number: 18004968
• Product Code: KNT
• UDI-Device Identifier: 00768455143016
• UDI-Public: 768455143016
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/11/2023
• 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