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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 Problems Loss of or Failure to Bond (1068); Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/30/2021
Event Type  malfunction  
Event Description
It was reported that, when the carrier of two (2) opsite flexifix gentle 2.5 cm x 5 m roll was withdrawn, much of the silicone adhesive was removed with the carrier and did not remain on the film.Treatment was resumed, without any delay, with a competitor's back-up device.Patient was not injured as consequence of this problem.
 
Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.The visual inspection confirmed silicone remained on the carrier.The functional evaluation confirmed reduced adherence, establishing a relationship between the device and the reported event.The root cause was identified as a 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 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 Key12321136
MDR Text Key266660150
Report Number8043484-2021-01682
Device Sequence Number1
Product Code KGX
UDI-Device Identifier05000223480363
UDI-Public5000223480363
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/14/2021
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 Expiration Date03/01/2022
Device Catalogue Number66801195
Device Lot Number1369882011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/30/2021
Initial Date FDA Received08/13/2021
Supplement Dates Manufacturer Received09/10/2021
Supplement Dates FDA Received09/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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