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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC INC. ABVISER AUTOVALVE IAP MONITORING DEVICE, POLE; DEVICE, CYSTOMETRIC, HYDRAULIC
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CONVATEC INC. ABVISER AUTOVALVE IAP MONITORING DEVICE, POLE; DEVICE, CYSTOMETRIC, HYDRAULIC Back to Search Results
Model Number ABV301
Device Problem No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2015
Event Type  malfunction  
Event Description
It was reported the auto valve on the intra-abdominal pressure monitoring device was closed and could not be reopened during use.The device was discontinued.No patient complications were reported as a result of this even.
 
Manufacturer Narrative
Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Should additional information become available, a follow-up report will be submitted.
 
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Brand Name
ABVISER AUTOVALVE IAP MONITORING DEVICE, POLE
Type of Device
DEVICE, CYSTOMETRIC, HYDRAULIC
Manufacturer (Section D)
CONVATEC INC.
211 american ave.
greensboro NC 27409
Manufacturer Contact
matthew walenciak, director
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4726804
MDR Text Key21081145
Report Number1049092-2015-00219
Device Sequence Number1
Product Code FEN
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/16/2017
Device Model NumberABV301
Device Lot Number1040600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2014
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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