MAUDE Adverse Event Report: CONVATEC LTD L3W1450 - SENSI-CARE; BANDAGE, LIQUID, SKIN PROTECTANT

Model Number TR108-25

Device Problem Flare or Flash (2942)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 03/25/2022

Event Type  malfunction  

Event Description

It was reported that the skin barrier applicator was used as skin protection before applying negative pressure wound therapy (npwt) and because it was bleeding from the wound surface and diathermy was used.The fumes from applicator ignited and inflicted a local first/second degree burn on the patient.There was blistering as well.The problem was that applicator was used prior to diathermy / electric surgery and then it got inflamed.It was thought that the product insert was not good enough in explaining this warning.

Manufacturer Narrative

Complainant city: (b)(6).Complainant postal code: (b)(6).Complainant state/province: (b)(6).Complainant country: (b)(6).Name of affiliation:(b)(6) hospital.Based on the available information, this event is deemed to be a reportable malfunction.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).

• Brand Name: L3W1450 - SENSI-CARE
• Type of Device: BANDAGE, LIQUID, SKIN PROTECTANT
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14247533
• MDR Text Key: 295874741
• Report Number: 1000317571-2022-00072
• Device Sequence Number: 1
• Product Code: NEC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TR108-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2022
• 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
• Patient Sex: Female