MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST-OP VISIBLE 16X11CM JP CTN 20; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66800144

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2020

Event Type  Injury  

Event Description

It was reported that the dressing could not be taken out of the sterile pouch because it had been trapped in the sealing part of the pouch.The treatment was done with some gauze because there was no other dressing there.No delay in treatment.The sample will not be returned and further information is not available.

Manufacturer Narrative

The device intended for use in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.Probable root cause includes operator inspection failure during production process.Medical review concluded, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.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+ nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE POST-OP VISIBLE 16X11CM JP CTN 20
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10231068
• MDR Text Key: 197643644
• Report Number: 8043484-2020-01533
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04582111152091
• UDI-Public: 4582111152091
• Combination Product (y/n): N
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800144
• Device Lot Number: 2019471
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/05/2020
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention