MAUDE Adverse Event Report: CONVATEC INC SENSI-CARE; PROTECTOR, OSTOMY

Model Number	423285
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: complainant city: (b)(4).Complainant country: finland.Based on the available information, this event is deemed to be a reportable malfunction.The device has malfunctioned and would be likely to cause or contribute to a death or serious injury if it were to recur.Based on the circumstances of the reported complaint, the case has been submitted as a reportable malfunction and there was minor harm to the patient, and it has been reported under imdrf health impact code and clinical code.A review of the ifu noted the flammable warnings are included on the product and the product packaging has the necessary warning symbols to highlight this.The ifu also includes warnings to keep away from ignition sources.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: (b)(4) manufacturing site: (b)(4).
Event or Problem Description
The nurse reported that the surgeon had applied the company's known skin barrier foam applicator (sting free) around the wound of the patient before securing the vacuum-assisted closure (vac) system and used an electric cautery device (diathermy) for one button push only on the edge of the wound, due to this, the foam applicator on the skin and the wound sponge caught on fire.This resulted in a burn injury to the patient.The product was not returned.No photo was available at this time.

• Brand Name: SENSI-CARE
• Common Device Name: PROTECTOR, OSTOMY
• 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: 17008602
• Report Number: 1049092-2023-00154
• Device Sequence Number: 7493146
• Product Code: EXE
• UDI-Device Identifier: 00768455197361
• UDI-Public: 00768455197361
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 423285
• Device Catalogue Number: 423287
• Device Lot Number: T2953
• 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: 05/02/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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