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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); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that there were water droplets on the surface of the inner tube. The product was not used on the patient. Photographs depicting the issue were received from the complainant.
 
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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 Key13565526
MDR Text Key286003284
Report Number1000317571-2022-00015
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,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number187930
Device Lot Number0A01790
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/30/2020
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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