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

Catalog Number 403100

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 03/14/2019

Event Type  Injury  

Event Description

Client alleges skin lacerations are due to smith & nephew skin prep and remover.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that lacerations were not severe and no medical intervention was required to correct this.There is no indication that the lacerations were caused by the product, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• 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 ; UK
• MDR Report Key: 8490110
• MDR Text Key: 141158648
• Report Number: 8043484-2019-00243
• Device Sequence Number: 1
• Product Code: KOX
• 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: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 403100
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention