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

Catalog Number UNKN05003200

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

Patient Problems Impaired Healing (2378); Localized Skin Lesion (4542)

Event Date 05/24/2021

Event Type  Injury  

Event Description

It was reported that, when using exu-dry dressing to treat patients with skin sloughing disorders, the wound of one patient deteriorated after treatment.No further information was provided regarding the reported event.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.

Manufacturer Narrative

The device used in treatment was not returned for evaluation, with all information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause includes application technique, good wound contact is essential.Daily dressing changes are recommended.No lot/serial number has been provided; therefore, a document review is not possible.A complaint history review was performed and showed other related failures.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain the reported failure/harm or event.However, the clinical review has not established a causal link.Additional rmr is not required.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: UNKN EXUDRY
• Type of Device: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11939455
• MDR Text Key: 254285229
• Report Number: 8043484-2021-01359
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05003200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention