MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE INCISE 28X30CM CTN 10; TAPE AND BANDAGE, ADHESIVE

Model Number 4987

Device Problem Microbial Contamination of Device (2303)

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

Event Date 08/10/2021

Event Type  malfunction  

Event Description

It was reported before use that a opsite incise 28x30cm ctn 10 had an insect-like foreign substance inside.No patient harm reported.

Manufacturer Narrative

H3, h6: the device was not used in treatment, has been returned and evaluated, establishing a relationship between the device and the reported event.Visual inspection confirmed the defect is insects on the handle release paper, with the root cause identified as a raw material quality issue.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported events.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 28X30CM CTN 10
• 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: 12375463
• MDR Text Key: 268437101
• Report Number: 8043484-2021-01699
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223415501
• UDI-Public: 05000223415501
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 09/22/2021

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
• Device Operator: Health Professional
• Device Model Number: 4987
• Device Catalogue Number: 4987
• Device Lot Number: 202001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1