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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 187932
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Initial reporter: patient country: (b)(6).Based on the available information, this event is deemed a reportable malfunction.Additional event information has been requested but, no information has been provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).
 
Event Description
It was reported that the primary pack has incomplete or open seal.It was further reported that ¿the medical staff withdraw the product from the primary pouch¿ but, it is unknown if the product was used on a patient.Photographs have been provided depicting the reported complaint issue.
 
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Brand Name
DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
Type of Device
DRESSING,WOUND,OCCLUSIVE
MDR Report Key7297662
MDR Text Key101154251
Report Number9618003-2018-00023
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 distributor,foreign
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/01/2022
Device Model Number187932
Device Lot Number7K00329
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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