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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. DURAFIBER AG 2X45 CTN 5 US; DRESSING,WOUND,HYDROPHILIC
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SMITH & NEPHEW MEDICAL LTD. DURAFIBER AG 2X45 CTN 5 US; DRESSING,WOUND,HYDROPHILIC Back to Search Results
Catalog Number 66800574
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2018
Event Type  malfunction  
Event Description
It was reported that strands of fiber were breaking off in the wound.The woc nurse had to pick the pieces out of the wound base.
 
Manufacturer Narrative
The associated complaint product was not returned for evaluation, please see below the results of our investigation: we have now concluded our investigation in to the reported complaint.As of today, no product return for this complaint has become available preventing a more thorough investigation.Without return of the actual device we cannot further investigate or confirm the details supplied in this complaint and try to determine a root cause.If the device is returned in the future then this complaint may be reopened.A dhr has not been possible as reasonable effort to obtain a lot number have not been successful.Complaints history review was run for the product code and fault reported, there have been no further complaints of this nature reported.On this occasion we have not been able to identify a definitive root cause for the device.Smith and nephew are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.
 
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Brand Name
DURAFIBER AG 2X45 CTN 5 US
Type of Device
DRESSING,WOUND,HYDROPHILIC
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK  HU3 2BN
MDR Report Key8204859
MDR Text Key131694943
Report Number8043484-2018-00467
Device Sequence Number1
Product Code NAC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800574
Was Device Available for Evaluation? No
Date Manufacturer Received12/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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