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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING DRESSING,WOUND,OCCLUSIVE

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CONVATEC DOMINICAN REPUBLIC INC DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 187658
Device Problem Difficult to Remove (1528)
Patient Problems Exposure to Body Fluids (1745); Irritation (1941); Pain (1994); Tissue Damage (2104); Discomfort (2330); Skin Tears (2516)
Event Date 05/30/2020
Event Type  malfunction  
Manufacturer Narrative
Device 1 of 1. (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
It was reported the end user had a panniculectomy procedure performed on (b)(6) 2017. Due to an irritation sustained recently at the waistline from wearing pants, the end user states his doctor's office recommended and provided the duoderm dressing to help reduce the irritation. The end user states he placed the dressing on the irritation area on saturday morning (b)(6) 2020, and during the process of removing the dressing on saturday afternoon the adhesive was way too powerful and resulted in tearing my skin and pulling out the pubic hairs located in that region. It appears to be a huge excoriation of that region as well as skin tore off, leaving an open area along with bruising resulting in severe pain and discomfort. End user reports he contacted his doctor's office and provided both a letter and photos of the irritated area. He was advised to discontinue using the dressing however; no medical treatment was provided. Photograph¿s were provided by the complainant of the irritated area. The end user stated that the area was now healing.
 
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Brand NameDUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
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
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key10164235
MDR Text Key195728683
Report Number9618003-2020-12072
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number187658
Device Lot Number9D01314Y
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received07/29/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/07/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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