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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 403326
Device Problem Difficult to Remove (1528)
Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Burning Sensation (2146); Discomfort (2330)
Event Date 05/04/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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
The end user's daughter reported that on (b)(6) 2021, the dressing was placed over slightly red area on the back to cover bed sores and prevent any further damage to his skin. It was left on overnight and the next morning on (b)(6) 2021, the end user complained of burning and itching. The entire area that the dressing covered 4 inches by 4 inches was damaged. The dressing was very difficult to remove since it had only been on less than 1 day and while removing, the end user yelled out in pain. It caused great discomfort to the end user. The end user's skin was intact just bright red and tender. A photograph depicting the issue was 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 Key11906537
MDR Text Key253843481
Report Number9618003-2021-01014
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 Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number403326
Device Lot Number0J00184
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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