MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 6.5X5CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66000708

Device Problems Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2020

Event Type  malfunction  

Event Description

It was reported that when the dressing was put on the patient skin, it was confirmed there were tiny black spots between the film and the pad.Please confirm the attached photo of the sample.Another opsite post op was used for treatment.No patient harm.No delay was reported.The sample will not be returned because of the contamination.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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.A complaint history review was carried out using the lot and part numbers provided, there have been no further complaints reported with these failure modes in the past three years.The product was used in treatment.As no product could be returned, a thorough evaluation of the product could not be carried out.It was report there were tiny black spots between the film and the pad, the photo provided by customer shows confirm the relationship between the event and the device.A full review of manufacturing process was carried out.The manufacturing of the dressings is carried out by laminating the pad and film.The pad and film material are supplied by third party supplier, the potential cause of this failure mode could have been due to the supplied material.However due to no sample being provided no further escalation.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 POST OP 6.5X5CM CTN 100
• Type of Device: 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: 10726253
• MDR Text Key: 212715048
• Report Number: 8043484-2020-03268
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04582111150899
• UDI-Public: 4582111150899
• 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: 12/18/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: 66000708
• Device Lot Number: 201907
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1