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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE2.5CMX5M; TAPE AND BANDAGE, ADHESIVE

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SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE2.5CMX5M; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Catalog Number 66801195
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Manufacturer Narrative
The device intended to be used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the product and reported event, or determine a root cause.Probable root cause may be due to component failure, the wound contact layer within these dressing can be affected by storage temperature fluctuations as detailed in the ifu.No lot/serial number has been provided, therefore a review of device history is not possible.A complaint history review has found other related events, with corrective action implemented related to the reported event.Smith + nephew will continue to monitor for adverse trends.
 
Event Description
It was reported that, during set-up/inspection of wound treatment, when the carrier was withdrawn, much of the silicone adhesive of (2) opsite flexifix gentle 2.5cm x 5m rolls removed with the carrier and did not remain on the film.Treatment was performed, without any delay, with a smith & nephew back-up device instead.Patient was not injured as consequence of this problem.
 
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Brand Name
OPSITE FLEXIFIX GENTLE2.5CMX5M
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
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK   HU3 2BN
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12747181
MDR Text Key279954699
Report Number8043484-2021-01926
Device Sequence Number1
Product Code KGX
UDI-Device Identifier05000223480363
UDI-Public5000223480363
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 11/03/2021
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 Number66801195
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/03/2021
Initial Date FDA Received11/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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