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

Catalog Number UNKN05004800

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 the control group 20 patient had the external dressing replaced at 48 hours and in the majority this was due to the leakage of exudate peripherally; in 10 of these cases the external dressing was replaced on more than one occasion and in five cases enough of the opsite had become detached to merit it being changed, in two patients.This happened on three occasions and these patients¿ donor site dressings were converted to vaseline gauze, dry gauze, gamgee and crepe.In only 10 of the in the experimental group was it necessary to re-apply the external dressing, and in the majority this was due to the presence of a localized collection of exudate.Four of there patients required to have the external dressing replaced on more than one occasion, but no patient required a change of opsitea and other four patients had small collections treated by aspiration only.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The devices used in treatment has not been returned for evaluation therefore we cannot establish a relationship between the devices and the reported events.Medical review concluded, the root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded at this time.Probable cause for the reported failure includes dressings left in place beyond the prescribed use.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.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, however at this time we have no reason to suspect that the product did not meet specifications at the time of manufacture.A complaint history review found other related failures.Our quality department will continue to monitor for trends.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• 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: 10230887
• MDR Text Key: 197926031
• Report Number: 8043484-2020-01433
• 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: 02/24/2021

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: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention