MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE INCISE 10X14CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Model Number	4963, 4975
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	06/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unknown product pack came with a foreign body.It is unknown whether this problem was noticed in a therapeutic environment or not; therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
H3, h6: the device, which was not used in treatment, was returned for evaluation.A visual inspection reported there was an insect between film and carrier, establishing a relationship between the device and the reported event.The root cause was identified as a raw material issue.No batch/lot number has been provided, therefore a review of the device history is not possible.A complaint history review found no further instances of the reported event.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 INCISE 10X14CM CTN 50
• 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: 12285714
• Report Number: 8043484-2021-01660
• Device Sequence Number: 14361349
• Product Code: KGX
• UDI-Device Identifier: 05000223415464
• UDI-Public: 05000223415464
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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 Model Number: 4963, 4975
• Device Catalogue Number: 4975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1