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

Catalog Number UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Code Available (3191); Unspecified Tissue Injury (4559)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that the aim of the study was to determine if ethamsylate could be used to reduce the problems associated with exudate collection when opsite was used as a donor site dressing.Once the skin had been harvested the donor sites were wrapped in moist saline packs until the remainder of the surgical procedure had been completed.The skin around the donor site was then dried and wiped with ether before a sheet of opsite, large enough to extend at least 5 cm beyond the raw edge of the donor site, was applied.The experimental group received 1 gram of ethamsylate intravenously immediately after the induction of general anaesthesia.Post- operatively they received 500mg of ethamsylate orally at 6-hourly intervals for 72 hours.The control group received only one tablet of a placebo (lactose) at 6-hourly intervals for 72 hours post-operatively.In two patients in each group the time until donor site healing exceeded 3 weeks.In two of these cases the healing donor site was traumatised with the opsite in situ, and in the remaining two cases the donor site was damaged by premature removal of the opsite.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.No additional information was provided, therefore, a relationship was not established between the device and the reported event.Root cause was not confirmed.There is no evidence to suggest a direct link between product and reported allegation.Review of manufacturing records could not be performed because the lot number was not provided.Complaint history review for three previous years indicated similar allegations.Instructions for use (ifu) contain recommendations and precautionary statements for proper use of product.Risk management files contain the reported allegation.No update required.Clinical/medical investigation was performed and determined no further actions required.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.

Event Description

It was reported that in the study "a new approach to the problems encountered with opsite as a donor site dressing: systemic ethamsylate" the healing donor site was traumatized with the opsite in situ.No further information was provided.

• 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: 10231035
• MDR Text Key: 197739549
• Report Number: 8043484-2020-01509
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2020
• 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: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention