MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ACTICOAT FLEX3 10X10CM CTN OF 5; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800398

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Date 02/03/2020

Event Type  Injury  

Event Description

It was reported that a very severe discoloration of the dressing and surrounding skin led the customers to think that the tissue was necrotized and further debridement was necessary.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaints history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this failure mode in the past three years.The device was used for treatment.It was reported that during treatment discolouration was identified on the dressing and surround skin site.The skin was then debrided as the discolouration was thought to be necrotised tissue.No images were provided of the reported issue.No samples were returned for evaluation.A clinical assessment was carried out.It was concluded; ¿no clinical/ medical documentation or pictures have been submitted to support this investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.¿ a risk management review was carried out.The risk files for this product captures local toxicity and local infection as harms related to using a discoloured dressing.No further actions are deemed necessary.Due to the properties of the material components of this dressing natural discolouration may occur.As stated in the ifu for this product ¿acticoat flex 3 may cause transient discolouration of the surrounding skin.The colour of the dressing may vary.This does not affect the performance of the dressing.¿ we have not been able to confirm a link between the event and description or identify a definitive root cause.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ACTICOAT FLEX3 10X10CM CTN OF 5
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 9743043
• MDR Text Key: 180844437
• Report Number: 8043484-2020-00127
• Device Sequence Number: 1
• Product Code: NAD
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800398
• Device Lot Number: 1917
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other