MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 15.5X8.5CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Model Number	66000712
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during set up or inspection, it was noticed that the adhesive of opsite post op dressings was weak so the release paper was separated, and the film part was sticking to the wrapping paper.3 dressings presented the failure mode.No case involved; therefore, no patient involvement.
Additional Manufacturer Narrative
The device intended to be used in treatment has not been returned for evaluation.The photo provided indicates film was delaminated from carrier and got creased, which confirms a relationship between the device and the event reported.The worn anti-adhesive roller had been identified as the root cause.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.The complaint history file contains further instances/related events of the reported events.This investigation is now complete with no further action deemed necessary at this stage.Smith and nephew will continue to monitor for any adverse trends relating to this product range.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment was sent for evaluation, however, the due to logistical issues the sample was sent to the wrong location and cannot be traced.Photographic evidence has been provided.A visual inspection of the image confirms reduced adherence, establishing a relationship between the device and the reported event.The root cause determined as a raw material issue.A review of the manufacturing records found that there was no evidence that the product did not meet specifications at the time of manufacture, a complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• Brand Name: OPSITE POST OP 15.5X8.5CM CTN 20
• 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: 11364403
• Report Number: 8043484-2021-00374
• Device Sequence Number: 16405627
• Product Code: KGX
• UDI-Device Identifier: 05000223441333
• UDI-Public: 05000223441333
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2021

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 Expiration Date: 09/01/2024
• Device Model Number: 66000712
• Device Catalogue Number: 66000712
• Device Lot Number: 201937
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 03/30/2021; 10/13/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 04/12/2021; 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1