MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKNOWN OPSITE POST OP VISIBLE; TAPE AND BANDAGE, ADHESIVE

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

Patient Problem No Information (3190)

Event Date 07/10/2019

Event Type  malfunction  

Event Description

It was reported that the opsite post op visible product leaves visible traces on the patient's skin, which do not disappear completely.The product would not produce the desired results and was therefore criticized.

Manufacturer Narrative

We have now concluded our investigation into this complaint.As the lot number could not be provided, we were unable to perform a review of the batch manufacturing records to assess any potential insight into the reported failure mode.No samples were received for this complaint therefore visual inspection and functional evaluation could not be performed.Further, no images were provided of the reported skin reaction and so, no further assessment on the relationship between the product and the reported failure mode can be made at this time.On this occasion we are unfortunately unable to reach a definitive root cause of the reported problem, however, if the product or additional information is received, the complaint will be reopened for investigation.

• Brand Name: UNKNOWN OPSITE POST OP VISIBLE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 8869005
• MDR Text Key: 153709816
• Report Number: 8043484-2019-00536
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 10/23/2019
• Patient Sequence Number: 1