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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 187955
Device Problem Difficult to Remove (1528)
Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Skin Irritation (2076); Swelling (2091); Burning Sensation (2146); Reaction (2414)
Event Date 12/30/2020
Event Type  malfunction  
Manufacturer Narrative
Device 9 of 12. (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 received 3 packs of dressings from the doctor. The end user was prescribed dermovate ointment to be used with dressings on left lower leg, which were to be changed daily. The end user applied 12 dressings on each of the first 12 days of treatment in conjunction with dermovate ointment (1 dressing used every day for 12 days). After 12 days, the area around the lesion being treated became red, irritated, swollen and itchy although the area on which the ointment had been spread was clear. The area that was in contact with the dermovate ointment did not cause a skin reaction. The dressings became more and more difficult to remove without causing pain. Initially, they were quite easy to remove. It was difficult to assess whether the dressings became more sticky, or simply more painful as the area became inflamed. The end user reported the problem to the general physician, who prescribed the treatment initially. The end user was not using any skin preparations other than the dermovate ointment in the center of the area covered by the dressing. The end user did not experience any bleeding and the skin was not broken, although the red area was raised slightly from the surrounding skin. The end user continued applying dermovate cream but three times a day rather than the one prescribed, leaving the area uncovered. The affected area was quite red and itchy. It was not particularly tender, but felt slightly sore. The end user applied dressings every two days, leaving the lesion without a dressing for the second day in each case. The end user now had 15 dressings left. The end user was not normally sensitive to plasters in any form. A photograph depicting the issue was received from the end user.
 
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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
Manufacturer (Section G)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer Contact
pamela meadows
7815 national service road
suite 600
greensboro, NC 27409
3365424679
MDR Report Key11213885
MDR Text Key228626191
Report Number9618003-2021-00128
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,Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number187955
Device Lot Number9J01954
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received12/05/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/15/2019
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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