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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that during the study clinical signs of wound infection were observed only in one patient in the citg group, for whom antibiotic therapy was initiated.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this product is not approved in the us.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

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.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 decreased absorption or reduced fluid uptake which among other harms can lead to wound maceration and/or infection.Without further details a full failure mode cannot be identified.A review of the instructions for use found adequate warnings, precautions relating to the product range.Bactigras is suitable for: wounds at risk of infection that cover no more than 10% of body area.Infected wounds in conjunction with systemic antibiotics.¿ minor burns and scalds, lacerations, abrasions and other skin loss wounds including donor and recipient graft sites.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 and revealed further instances, however no further action is deemed necessary at this time.This investigation has now been closed and recorded as insufficient information to determine a root cause, with no further actions deemed necessary.In parallel we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: UNKNOWN BACTIGRAS
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 9504748
• MDR Text Key: 172439878
• Report Number: 8043484-2019-00937
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• 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: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other