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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC, INC. AQUACEL AG SURGICAL COVER DRESSING; DRESSING, WOUND, HYDROPHILIC
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CONVATEC, INC. AQUACEL AG SURGICAL COVER DRESSING; DRESSING, WOUND, HYDROPHILIC Back to Search Results
Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported the "dressings often roll up at the edges because the patients are in bed, lying on the dressing, sliding around in bed, etc." no patient harms were reported as a result of this event.
 
Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.The total number of dressing and/or patients involved in this complaint is unknown.The model and lot numbers of the devices involved were not provided.No additional details were available at the time of this report.Should additional information become available a follow-up report will be submitted.
 
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Brand Name
AQUACEL AG SURGICAL COVER DRESSING
Type of Device
DRESSING, WOUND, HYDROPHILIC
Manufacturer (Section D)
CONVATEC, INC.
211 american ave.
greensboro NC 27409
Manufacturer Contact
matthew walenciak,interim assoc.
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4432400
MDR Text Key5376419
Report Number1049092-2015-00028
Device Sequence Number1
Product Code NAC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 06/23/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2011
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 Initial
Patient Sequence Number1
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