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

Model Number 4963, 4975

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

Event 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.

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
• 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: 12285714
• MDR Text Key: 265346486
• Report Number: 8043484-2021-01660
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223415464
• UDI-Public: 05000223415464
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1