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U.S. Department of Health and Human Services

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

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DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 187955
Device Problems Device Expiration Issue (1216); Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problems Bacterial Infection (1735); Inflammation (1932); Skin Irritation (2076); Tissue Damage (2104); Burning Sensation (2146); Ulcer (2274)
Event Date 03/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). Based on the available information, this event is deemed to be a serious injury. 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.   additional information has been requested, however 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 has been using the duoderm extra thin dressing for three (3) years as directed by her doctor to treat venous leg ulcers. End user reports that on (b)(6) 2018 she purchased duoderm et in the pharmacy within the neighborhood, however when she bought it, she did not verify expiration date. The dressing was given to end user's treating doctor for review and cure routine. Once the doctor placed the dressing on the wound, the end user reports burning and redness in the leg. The doctor verified the expiration date of dressing and it was dec-2017. It was stated that the doctor instructed the end user not to remove the dressing from the wound until the next day, despite knowing that it was obsolete. The next day when the dressing was removed, the ulcer showed a slight infection. End user states the ulcer is very large, her leg is totally swollen and she cannot walk. Her doctor removed the duoderm of her treatment and is using vaseline gel gauze and jelonet gauze.
 
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Brand NameDUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
Type of DeviceDRESSING,WOUND,OCCLUSIVE
MDR Report Key7473580
MDR Text Key106918818
Report Number9618003-2018-00145
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,foreign
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number187955
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/11/2018
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

Patient Treatment Data
Date Received: 04/30/2018 Patient Sequence Number: 1
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