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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC AQUACEL AG SCD DRS 9X25CM; DRESSING, WOUND, DRUG
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CONVATEC AQUACEL AG SCD DRS 9X25CM; DRESSING, WOUND, DRUG Back to Search Results
Model Number 412011
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
Healthcare professional calls and reports having a patient with dressing peeling off and using tape to reinforce.
 
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Brand Name
AQUACEL AG SCD DRS 9X25CM
Type of Device
DRESSING, WOUND, DRUG
Manufacturer (Section D)
CONVATEC
211 american ave
greensboro NC 27409
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5124845
MDR Text Key27392345
Report Number1049092-2015-30202
Device Sequence Number1
Product Code FRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091034
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number412011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2014
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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