MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN CUTICERIN; DRESSING, WOUND, DRUG

Catalog Number UNKN05002000

Device Problems Loss of or Failure to Bond (1068); Material Disintegration (1177)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was reported that, during burn treatment with a combination of an unknown cuticerin dressing and an unknown jelonet dressing, there were residues from these dressings that adhered to the wound.Patient also reported that dressings kept loosening and did not provide irritation relief in the wound area.As this was noticed in a retrospective post market clinical follow up activity, further information is not available.

Manufacturer Narrative

The device, used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.Probable root cause is application, and or product failure.No batch/lot number has been provided; therefore, a review of the device history has not been possible.A complaint history review found further instances of the reported events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Manufacturer Narrative

Section h10: the product, used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.No batch/lot number has been provided; therefore, a review of the device history has not been possible.A complaint history review found further instances of the reported event.There are no open or closed escalation actions within the scope of this case.The risk management documentation for cuticerin has been reviewed and confirmed the alleged failure and associated harms have been anticipated.The probable cause regarding the event remains unknown.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.Internal complaint reference number: (b)(4).

Event Description

It was reported that, during burn treatment with an unknown cuticerin dressing, there were residues from the dressing that adhered to the wound.Patient also reported that dressings kept loosening and did not provide irritation relief in the wound area.As this was noticed in a retrospective post market clinical follow up activity, further information is not available.

• Brand Name: UNKN CUTICERIN
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11881056
• MDR Text Key: 252942507
• Report Number: 8043484-2021-01198
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05002000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1