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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC INC AQUACEL FOAM; DRESSING,WOUND,HYDROPHILIC

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CONVATEC INC AQUACEL FOAM; DRESSING,WOUND,HYDROPHILIC Back to Search Results
Model Number 420633
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.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 ¿one side of aquacel foam dressing pouch is open.There is a piece of aquacel foam on the open side.¿ the product was not used on or by a patient.Photographs depicting the reported complaint issue were provided by the complainant.
 
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Brand Name
AQUACEL FOAM
Type of Device
DRESSING,WOUND,HYDROPHILIC
Manufacturer (Section D)
CONVATEC INC
211 american avenue
greensboro NC 27409
Manufacturer (Section G)
CONVATEC INC
211 american avenue
greensboro NC 27409
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key9049098
MDR Text Key206957297
Report Number1049092-2019-00229
Device Sequence Number1
Product Code NAC
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
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date09/01/2023
Device Model Number420633
Device Lot Number2704901
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/11/2019
Initial Date FDA Received09/13/2019
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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