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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC LTD L3W1275 - DUODERM PASTE AND GELS NOT APPLICABLE

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CONVATEC LTD L3W1275 - DUODERM PASTE AND GELS NOT APPLICABLE Back to Search Results
Model Number 187930
Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that there was container leakage which was evident prior to use. The tubes were not damaged and there was no visible cut or crack on primary package, but the secondary and primary packaging was greasy to touch. It was unknown if the product was used by the end user. Photographs depicting the issue were received from the complainant.
 
Manufacturer Narrative
Device 3 of 3. (b)(4). Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
 
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Brand NameL3W1275 - DUODERM PASTE AND GELS
Type of DeviceNOT APPLICABLE
Manufacturer (Section D)
CONVATEC LTD
first avenue
deeside industrial park
deeside, flintshire CH5 2 NU
UK CH5 2NU
Manufacturer (Section G)
CONVATEC LTD
first avenue
deeside industrial park
deeside, flintshire CH5 2 NU
UK CH5 2NU
Manufacturer Contact
pamela meadows
7815 national service road
suite 600
greensboro, NC 
3365424679
MDR Report Key13106737
MDR Text Key284988775
Report Number1000317571-2021-00257
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number187930
Device Lot Number0B02944
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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