MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. REPLICARE THIN DRESS 3.5X5.5IN; DRESSING,WOUND,OCCLUSIVE

Model Number 59484100

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

Patient Problem Skin Erosion (2075)

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during wound treatment with replicare thin dress 3.5x5.5in, on follow up visit, substantial excoriation was noted on one patient.The usage of the dressing was suspended immediately.The treatment was completed using a vac therapy, and the patient received steroids and antifungal oral medications to treat the excoriation.No other complications were reported.

Manufacturer Narrative

H3, h6: the device, was not returned for evaluation, all provided information has been reviewed and we have not been able to confirm the reported event.Medical review concluded, he information provided is insufficient to determine whether the patient¿s symptoms are due to a pre-existing or concurrent medical condition (allergy history, skin/dermal sensitivities).The ifu highlights that the dressing should not be used on patients with known sensitivities.It was further communicated, the use of the replicare thin dress was suspended immediately and the treatment was completed using vac therapy, steroids, and an antifungal oral medication for the excoriation.In addition, an extra layer of cavilon skin protectant was used as the peri-wound healed.Since no other complications were reported, no further medical assessment is warranted at this time.A documentation review has been conducted, confirming previous complaints of this nature.No historical escalations or manufacturing problems were observed.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.This investigation is now complete, with no manufacturing problems observed, no corrective actions are deemed necessary.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.

• Brand Name: REPLICARE THIN DRESS 3.5X5.5IN
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12725470
• MDR Text Key: 279249845
• Report Number: 8043484-2021-01918
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 00040565115566
• UDI-Public: 00040565115566
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: 59484100
• Device Catalogue Number: 59484100
• Device Lot Number: C2007241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other