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

Catalog Number	66000708
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference number: (b)(4).
Event or Problem Description
It was reported that, during the set up for a wound treatment, it was noticed that there was a black 2×1mm foreign substance between the film and the pad of the dressings from a opsite post op 6.5x5cm ctn 100 box.Treatment was performed without any delay, with a back up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may include raw material issue, the film or pad within the dressing may bring in foreign substance.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found further instances of the reported event.The risk files mitigate the reported issue with no updates required.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE POST OP 6.5X5CM CTN 100
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12755725
• Report Number: 8043484-2021-01931
• Device Sequence Number: 19915119
• Product Code: KGX
• UDI-Device Identifier: 05000223441227
• UDI-Public: 5000223441227
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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: 05/01/2026
• Device Catalogue Number: 66000708
• Device Lot Number: 202118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 11/06/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown