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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0750 - DUODERM DRESSING,WOUND,OCCLUSIVE

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CONVATEC DOMINICAN REPUBLIC INC L3W0750 - DUODERM DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 187957
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that two packages were not sealed because dressing was trapped inside the inside. The product was not used. Photographs depicting the issue were received from the complainant.
 
Event Description
It was reported that two packages were not sealed because dressing was trapped inside the inside. The product was not used. Photographs depicting the issue were received from the complainant.
 
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Brand NameL3W0750 - DUODERM
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal 91000
DR 91000
Manufacturer (Section G)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal 91000
DR 91000
Manufacturer Contact
pamela meadows
MDR Report Key13576978
MDR Text Key285986608
Report Number9618003-2022-00187
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,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number187957
Device Lot Number1E01721
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2022
Was the Report Sent to FDA? No
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/06/2021
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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