MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN OPSITE; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNKN05004800

Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Information (3190)

Event Type  Injury  

Event Description

It was reported that aim of this study was to compare the healing rate of burns using honey impregnated gauze and a commercially available dressing, opsite.After initial management, patients were allotted at random to two groups.In group, sterile honey impregnated gauze was applied over the burn area after washing with normal saline and covered with pads and bandage.In group 2, the wounds, after washing with normal saline, were covered by bio-occlusive, moisture-permeable polyurethane dressing (opsite, smith and nephew, (b)(6)).Of the 46 cases, infection was found in 17, of those the dressing required changing in 5 cases between 3-5 days because of exudate oozing from underneath the dressing.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device used in treatment was not returned for evaluation with no additional information provided we have not been able to establish a relationship between the reported event or determine a root cause.Probable root causes include application techniques and or a failed component.The instructions for use offers further guidance.Medical review concluded, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.No batch/lot number has been provided, therefore a review of the device history has not been possible.A complaint history review found other related failures.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: UNKN OPSITE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10230920
• MDR Text Key: 197588540
• Report Number: 8043484-2020-01453
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention