• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONVATEC DOMINICAN REPUBLIC INC L3W0750 - DUODERM DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 187971
Device Problem Difficult to Remove (1528)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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
It was stated that the end user applied dressing to a "bed sore¿ and it had a stronger adhesive than the previous company dressing without border used in the past. This made it more difficult to remove and resulted in skin irritation where applied. The end user had used a different company dressing without the border in the past without any issue. No photo is available at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12279710
MDR Text Key265126936
Report Number9618003-2021-01648
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 health professional
Type of Report Initial
Report Date 07/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number187971
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/15/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-