MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKNOWN BIOBRAME; DRESSING,WOUND,OCCLUSIVE

Catalog Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that in a single-center, prospective, randomized clinical trial three different configured wound dressings biobrane, dressilk, and polymem were compared with each other regarding objective and subjective healing parameters and cost-efficiency.During the study, patient 17 at postoperative day 16 presented mild signs of infection (i.E.Exudation, swelling, and redness), the infection spread primarily from the wound area covered with biobrane.

Manufacturer Narrative

The device intended for use in treatment, or a control sample, has not been returned for evaluation.Without this we are unable to complete an analysis to establish a relationship between device and the failure reported.However, this is understandable as the complaint has been raised following a literature review of biobrane, published in 2016.Medical/clinical investigation concluded that the information provided was via a literature review.However, without the requested patient specific information, a thorough medical investigation cannot be rendered.Should any additional medical information be provided this complaint will be re-assessed.A risk management review has taken place in relation to this complaint, the risk file contains multiple causes of local infection.These range from over stretching the dressing upon application, not sealing the dressing fully, not cleaning the wound before application, cross contamination and the dressing not allowing fluid to escape on initial application.Without further information this cannot be narrowed down any further to a more specific failure mode.A review of the instructions for use found adequate warnings, precautions relating to the product range.Caution: if bleeding occurs, or if patient complains of excessive pain, stop and wait 1 to 2 additional days.Forced removal may result in wound re-injury.If biobrane becomes adherent to a partial thickness wound which has progressed to a full thickness wound, it should be removed in the operating room prior to autografting.Warning: in rare instances, allergic reactions to biobrane have been reported.If a patient shows evidence of allergic reaction, biobrane should be removed and its use discontinued.A review of the device history has also not been possible, as no lot/part number has been provided, however all products released are done so according to design specification, there is no indication that the product failed to meet this.Complaint history for the reported failure has been reviewed, revealing further instances, however no further action is deemed necessary at this time.We have been unable to determine a root cause on this occasion.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: UNKNOWN BIOBRAME
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 9526983
• MDR Text Key: 173084042
• Report Number: 8043484-2019-00964
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other