MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 9.5X8.5CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Model Number 66000709

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 05/11/2021

Event Type  malfunction  

Event Description

It was reported that, before the product was sent to a healthcare facility, was found the opsite post op 9.5x8.5cm ctn 20 had a foreign substance on the dressing.No case involved; therefore, no other complications were reported.

Manufacturer Narrative

The device intended to be used in treatment has been returned and evaluated, establishing a relationship with the reported event.The assessment confirmed that the thread-like foreign substance in the pad, with the root cause identified as pad raw material quality issue.The manufacturing record 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 POST OP 9.5X8.5CM CTN 20
• 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: 11892759
• MDR Text Key: 252940011
• Report Number: 8043484-2021-01254
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223441241
• UDI-Public: 05000223441241
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

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: 66000709
• Device Catalogue Number: 66000709
• Device Lot Number: 202014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1