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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 WINDOW FRAME 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

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SMITH & NEPHEW MEDICAL LTD. IV3000 WINDOW FRAME 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaints history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this failure mode in the past three years.The device is intended for use in treatment.It was reported that the dressings had low adhesion, a creased film and that the carrier was raised.Images provided showed the issue of delamination.The returned dressings were evaluated.A visual inspection did not identify a creased film on any of the dressings.During a functional evaluation low adhesion was not found on any of the dressings.However delamination was identified on three of five returned dressings.Delamination is a low level intermittent fault which if seen is tabbed for removal during the conversion process.During the manufacturing of the dressing, in process checks are undertaken for this product.All material is manufactured according to the specification and only product meeting the release criteria will be passed on for further processing.We have not been able to confirm a relationship between the reported low adhesion and creasing and the device.We were, however, able to confirm a relationship between the reported raised carrier and the device.The root cause was determined as a manufacturing defect.As this is a very low occurring issue, no further actions are deemed necessary.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
 
Event Description
It was reported that during investigation was found that three dressing presented delamination problems.No patient involved.
 
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Brand Name
IV3000 WINDOW FRAME 6X7CM CTN 100
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hussle road
hull HU3 2 BN
UK  HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull
UK  
Manufacturer Contact
sarah freestone
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
4407940038
MDR Report Key10129434
MDR Text Key194357574
Report Number8043484-2020-00670
Device Sequence Number1
Product Code KGX
Combination Product (y/n)N
Reporter Country CodeCH
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 06/08/2020
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
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/01/2020
Initial Date FDA Received06/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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