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

Catalog Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2020

Event Type  malfunction  

Event Description

It was reported that water proof band aid dressings don¿t stick and stay on.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no part or lot numbers were provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaint history review was carried out across the product family, there have been further complaints reported with this failure mode in the past three years.The device was used for treatment.It was reported that the dressing did not adhere to the patient¿s skin satisfactorily.As no samples were returned a thorough product evaluation could not be carried out.Low adhesion may be caused by adhesion levels of the raw material used to make the film of this dressing.There are various controls in place during the manufacturing process of both the raw material and the dressing to identify when the adhesion is not in acceptable range, as per the product specification.There are also regular tests carried out to monitor the finished product.As with all adhesive products, the skin site must be thoroughly cleaned and dried prior to application.If there is any moisture on the skin site, the adhesive performance of this dressing may be compromised.We have not been able to confirm a relationship between the event and the device.The root cause remains undetermined.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: UNKNOWN OPSITE
• 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: 10683881
• MDR Text Key: 211481702
• Report Number: 8043484-2020-03214
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1