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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 Problem 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 surgical dressings have been rolling up on patient's when applied to spinal surgical sites.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 dressings 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.(b)(4).
 
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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 Key4432399
MDR Text Key5419752
Report Number1049092-2015-00029
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 Other Health Care Professional
Type of Report Initial
Report Date 09/12/2014
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 Received09/12/2014
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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