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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE 5CM X 1M; TAPE AND BANDAGE, ADHESIVE

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SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE 5CM X 1M; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Catalog Number 36361379
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  malfunction  
Event Description
It was reported that, during treatment with opsite flexifix gentle 5cm x 1m, the customer bought the dressing and the adhesives got stuck and remained on the plastic backing.It is unknown how treatment was resumed.Patient was not harmed.
 
Manufacturer Narrative
H3, h6: the device used in treatment has been returned and evaluated, establishing a relationship between the event reported.Visual inspection confirmed the adhesive was stuck and remained on the plastic backing.Root caused determined as component failure.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances.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.
 
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Brand Name
OPSITE FLEXIFIX GENTLE 5CM X 1M
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 Key11995537
MDR Text Key256076704
Report Number8043484-2021-01459
Device Sequence Number1
Product Code KGX
UDI-Device Identifier09330169004610
UDI-Public9330169004610
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number36361379
Device Lot Number1357451929
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2021
Initial Date Manufacturer Received 05/27/2021
Initial Date FDA Received06/14/2021
Supplement Dates Manufacturer Received06/23/2021
Supplement Dates FDA Received06/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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