MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. DURAFIBER 4X10 CM; DRESSING,WOUND,HYDROPHILIC

Catalog Number 66800546

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that part of product remained in patient's lower back wound post removal of dressing, resulting in infection, readmission and surgical intervention.

Manufacturer Narrative

H3, h6: 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 further instances/ related events of the reported event.The device was used for treatment.No samples were returned for analysis.The reported issue may be attributed to procedural technique.A clinical investigation concluded; this case report that fibers from the durafiber dressing remained in the patient¿s lower back wound ¿resulting in infection.¿ per e-mail communication the patient started using the dressing on (b)(6) 2020, and the dressing was supposed to be changed daily, however the patient missed some appointments.After 17 days of use the last date of removal was noted as (b)(6) 2020.Treatment was continued with topical dressing.It was also communicated that the patient was admitted to the hospital on (b)(6) 2020 for an unknown surgical intervention to treat the reported infection.Although requested, no photos, operative notes, or labs results have been provided for review.The instructions for use provides comprehensive instructions of the operation, use and limitations of the device.The associated risk file contains the reported event.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.

• Brand Name: DURAFIBER 4X10 CM
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11068834
• MDR Text Key: 223594770
• Report Number: 8043484-2020-04368
• Device Sequence Number: 1
• Product Code: NAC
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800546
• Device Lot Number: 1909
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention