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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE 5CMX5M; TAPE AND BANDAGE, ADHESIVE
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SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE 5CMX5M; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Catalog Number 66801196
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  malfunction  
Event Description
It was reported that silicone layer of three opsite flexifix gentle 5 cmx5 m sticks to the cover film and does not come off properly.No case involved; therefore, no other complications were reported.
 
Manufacturer Narrative
The renasys pump device, used in treatment, has not been returned for evaluation.All provided information has been reviewed, we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable cause includes a component failure.No batch/lot number has been provided, therefore a review of the device history records has not been possible, 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 further instances of the reported event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
 
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Brand Name
OPSITE FLEXIFIX GENTLE 5CMX5M
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 Key12001189
MDR Text Key256268551
Report Number8043484-2021-01471
Device Sequence Number1
Product Code KGX
UDI-Device Identifier05000223480387
UDI-Public5000223480387
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66801196
Was Device Available for Evaluation? No
Date Manufacturer Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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