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

Catalog Number UNKNOWN

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

Patient Problems Purulent Discharge (1812); Tissue Damage (2104)

Event Date 01/01/1901

Event Type  Injury  

Event Description

That this study was approved by the institutional review board of the university of texas medical branch along with the institutional irb approval at christian medical college, vellore, tn, india.The aim of this prospective randomized controlled study was to compare helicoll® (encoll corp., fremont, ca, usa), a type i pure collagen dressing, to opsite® (smith & nephew, usa) dressing and to scarlet red® (kendall healthcare, usa) dressing in the treatment of standardized split thickness skin graft (stsg) donor sites.Patients were randomized to receive opsite, scarlet red or helicoll as a donor site dressing.The patients stayed in the hospital for 24 h after their surgery, where dressings were changed if necessary, and all patients received a standard post-operative oral analgesic and discharged home to be seen in the clinic on the fifth post-operative day.Three patients had yellow discharge under the wrinkled opsite and required removal and daily dressing change with adaptic and bacitracin ((b)(4)).Four patients had purulent exudates associated with redness ((b)(4)).Patients were diagnosed clinically to have donor site wound infection, but no cultures were obtained.

Manufacturer Narrative

H3, h6: the device used in treatment was not returned for evaluation.No additional information was provided, therefore, a relationship was not established between the device and the reported event.Visual and functional evaluations were not possible without product available.Review of manufacturing records could not be performed because the lot number was not provided.At this time we have no reason to suspect that the product failed to meet specifications upon release to distribution.Complaint history review for three previous years indicated similar allegations.Instructions for use (ifu) contain recommendations and precautionary statements for proper use of product.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.Root cause was not confirmed.There is no evidence to suggest a direct link between product and reported allegation.Potential factors that may have contributed to the reported failure might be: patient sensitivity, allergic reaction, application or dressing difficulties.Smith and nephew will continue to monitor for any adverse trends relating to the reported allegation.No further investigation required at this time.Clinical/medical investigation was performed and determined no further actions were required.

• Brand Name: UNKNOWN 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: 10244338
• MDR Text Key: 198384893
• Report Number: 8043484-2020-01759
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 06/15/2020
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other