MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. REMOVE WIPES BOX OF 50 01; SOLVENT, ADHESIVE TAPE

Catalog Number 403100

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

Patient Problem Burn(s) (1757)

Event Date 02/09/2021

Event Type  Injury  

Event Description

It was reported that the customer used the ¿remove¿ adhesive removal wipes and it caused welts on her skin and burning.She normally uses something else.(b)(4), the company that sent her these wipes, sent her the wrong product.It is unknown if there was any medical intervention needed to treat her condition.

Manufacturer Narrative

H3, h6: the device that was 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 may include an allergic reaction.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture, the reported file is held by the quality release team.A complaint history review found further instances of the reported event.The associated risk files contain details relating to harm.No further action is required.Instructions for use contains recommendations and precautionary statements for proper use of product.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: REMOVE WIPES BOX OF 50 01
• Type of Device: SOLVENT, ADHESIVE TAPE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11429969
• MDR Text Key: 238338535
• Report Number: 8043484-2021-00511
• Device Sequence Number: 1
• Product Code: KOX
• UDI-Device Identifier: 40565115665
• UDI-Public: 40565115665
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 403100
• Device Lot Number: 2139
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention