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

Model Number 66047578

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

Patient Problem Injury (2348)

Event Date 09/18/2020

Event Type  Injury  

Event Description

It was reported that the dressing was cut into spectacles shape, skin bleeding, skin off was found 1 hour later after the surgery.The doctor immediately uncovered the dressing, and removed the dressing and also the skin adhered.The rest scattered in the purple appeared after applying the dressing.The patient denied allergy history.The patient presented with bilateral nasal congestion 2 years ago.She was admitted to hospital for nasal septum deviation on (b)(6) 2020.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.The complaint history file contains no further instances/ related events of the reported event.The device was used for treatment.The returned samples were evaluated.No visual or functional issues were identified.The reported issue may be linked to procedural technique.A clinical investigation concluded: the provided photos of the patient¿s face post procedure show the exposed dermal layer of skin with skin tearing and bruising.Based on the 2018 article, ¿review of disinfection and sterilization¿ iodine is an oxidizing agent.The ifu for allevyn thin precautions against combining the use of this dressing with oxidizing agents such as hypochlorite solutions or hydrogen peroxide solutions.It cannot be concluded that the technique in which the dressing was applied and/or removed contributed to the bleeding and adherence of the patient¿s skin to the allevyn thin dressing.Therefore, the root cause of the reported injury to the patient¿s face cannot be definitively determined.However, we cannot rule out a procedural related event as the likely cause of the injury to the patient¿s skin.It was reported the doctor immediately uncovered the dressing and treated the affected area with dermolin (gauze mesh) and it was also ordered to be applied with further treatments.The impact to the patient is the facial injuries, frequent dressing changes, potential for infection, pain and the potential for further wound care treatment.The current status of the patient is unknown.We have not been able to confirm a relationship between the event and the device 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.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.Case-2020-00020042-1.

• Brand Name: ALLEVYN THIN 10X10CM CTN 5
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10673695
• MDR Text Key: 211220464
• Report Number: 8043484-2020-03192
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223452919
• UDI-Public: 05000223452919
• 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: 03/12/2021

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 Model Number: 66047578
• Device Catalogue Number: 66047578
• Device Lot Number: 1924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention