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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

Reference number: (b)(4).

Event Description

It was reported that when using replicare ultra dressing to treat pressure ulcers or injuries, 1 patient reported occasional co-infection.It is unknown if/how the adverse event was treated.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it, we do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.

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 product and reported event or determine a root cause.Probable root of the reported infection may be improper preparation of wound area or application of dressing which, if done incorrectly may leave the wound exposed to infection-causing bacteria.No lot/serial number has been provided therefore a review of device history is not possible.A complaint history review found further instances of the reported events.The instructions for use has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.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.

• Brand Name: UNKN REPLICARE
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 12440713
• MDR Text Key: 270349485
• Report Number: 8043484-2021-01726
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention