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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 187660
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Correction - contact office address: dr. (b)(4). (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).
 
Event Description
It was reported that the package was unsealed. The product was not used on patient. 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
7815 national service road
suite 600
greensboro, NC 
3365424679
MDR Report Key12525191
MDR Text Key273103113
Report Number9618003-2021-02284
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 distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number187660
Device Lot Number9E05062
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received10/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2019
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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