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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Impaired Healing (2378); 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.

• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 0447940038
• MDR Report Key: 10231036
• MDR Text Key: 197739475
• Report Number: 8043484-2020-01510
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/05/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention