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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: L3W0750 - DUODERM DRESSING,WOUND,OCCLUSIVE

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L3W0750 - DUODERM DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 187955
Device Problem Difficult to Remove (1528)
Patient Problems Hemorrhage/Bleeding (1888); Skin Tears (2516); Tissue Breakdown (2681)
Event Type  malfunction  
Manufacturer Narrative
Device 4 of 4. Based on the available information, this event is deemed to be a reportable malfunction. This complaint has been evaluated. No lot number is available. A detailed investigation or batch review cannot be conducted. Therefore, this evaluation will be closed. This issue will be monitored through the post market product monitoring review process. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
 
Event Description
End user¿s daughter who is also the care provider reported that they had been using this product for many weeks and that it was prescribed by the consumer's doctor of medicine (md). She purchased it from a local pharmacy with a prescription. The prescription stated to change the product every three days. She uses two 4x4 dressings with each change to cover the wounds. She stated that the wounds had been healing with use of the product and that it usually was very easy to remove on the third day. The complaint product was from a new market unit. She stated that when she went to remove the dressing, it appeared like it was glued to her skin and she had great difficulty removing it. The force of the removal caused skin tearing. She stated that the skin started to bleed due to the skin tearing. She cleaned the wound and skin tore and she applied two new dressings from the same market unit. The complainant reported that the same thing happened that day and she was not able to remove the dressings due to them being adhered like glue to the skin. Hence, a total of four dressings were used. The product was used on patient. No photo is available at this time.
 
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Brand NameL3W0750 - DUODERM
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer Contact
pamela meadows
7815 national service road
suite 600
greensboro, NC 
3365424679
MDR Report Key14039703
MDR Text Key288794213
Report Number9618003-2022-00466
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
Report Date 03/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number187955
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? No
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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