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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 10; TAPE AND BANDAGE, ADHESIVE

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SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 10; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Catalog Number 66004005
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/03/2019
Event Type  malfunction  
Event Description
It was reported that the adhesive strength is not hard enough.It was reported that during treatment the dressing presents low adhesion.No harm nor injury reported.
 
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 number provided, there have been further complaints reported with this issue in the past four years.It was reported that the product was used for treatment in which the dressings were found to have low adhesion.As no samples were returned, a functional evaluation was not possible.However, images received show the dressing was not fully adhered.This confirmed a relationship between the event and the device.Low adhesion may be caused by adhesion levels of the raw material used to make the film of this dressing.There are various controls in place during the manufacturing process of both the raw material and the dressing to identify when the adhesion is not in acceptable range, as per the product specification.There are also regular tests carried out to monitor the finished product.The root cause was determined as manufacturing process error.As this is a low occurring issue and controls are in place to monitor this issue, no further actions by smith and nephew are deemed necessary at this stage.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.
 
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Brand Name
IV3000 1 HAND 10X12CM CTN 10
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK  HU3 2BN
MDR Report Key9517214
MDR Text Key174182191
Report Number8043484-2019-00951
Device Sequence Number1
Product Code KGX
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/24/2020
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
Device Catalogue Number66004005
Device Lot Number1908
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/27/2019
Initial Date FDA Received12/24/2019
Supplement Dates Manufacturer Received02/24/2020
Supplement Dates FDA Received03/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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