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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 187955
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Wheal(s) (2241)
Event Date 01/08/2020
Event Type  Injury  
Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury. 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 reports she had placed the dressing over a scar on her right knee at approximately 10 pm. She is six weeks post op from a knee replacement, and her doctor approved the dressing be placed on the scar. Approximately five hours later, at 3 am, she awoke with itching of both arms and under her breasts. She noted hives on both arms. She states her knee felt hot under the dressing. She removed the dressing and said her skin was clear and intact under the dressing. She took a prescription allergy pill, hydroxyzine hydrogen chloride (hcl), which she had on hand for her seasonal allergies and was not prescribed for this event. She removed and discontinued the product. She went back to bed, and when she woke up, she felt much better. She reports that all the symptoms resolved, except she still had some slight itching by her elbows and under her breasts.
 
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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
pamela meadows
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key9602962
MDR Text Key175444965
Report Number9618003-2020-00423
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
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number187955
Device Lot Number9A00460Y
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/08/2020
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

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