MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIGRID 10X12CM USA CTN 10; TAPE AND BANDAGE, ADHESIVE

Catalog Number	66024629
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that customer after getting a tattoo used opsite 6x7 to try and cover her piece and the ends kept curling up, customer used hospital tape to hold them down, however that caused the film to come off further then customer used opsite 10x12 to ensure it was fully covered and the second sealed that however customer still has a large piece that has not stuck down.No harm or injury reported.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.The complaint history file contains no further instances/ related events of the reported event.The device was used for treatment.As the device was not returned, a thorough product evaluation could not be carried out.Images provided confirmed a relationship between the event and the device.However without return of samples, we have not been able to determine a definitive root cause.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 surrounding the catheter, the adhesive performance of this dressing may be compromised.If the dressing becomes wet whilst applied, it may have to be removed and a new dressing applied.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: OPSITE FLEXIGRID 10X12CM USA CTN 10
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11139698
• Report Number: 8043484-2021-00065
• Device Sequence Number: 19844296
• Product Code: KGX
• UDI-Device Identifier: 05000223438517
• UDI-Public: 5000223438517
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 66024629
• Device Lot Number: 1946
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1