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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC INC. ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVICE; DEVICE, CYSTOMETRIC, HYDRAULIC
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CONVATEC INC. ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVICE; DEVICE, CYSTOMETRIC, HYDRAULIC Back to Search Results
Model Number ABV301
Device Problem Blocked Connection (2888)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/02/2014
Event Type  malfunction  
Event Description
It is reported that the auto valve did not open resulting in no urine efflux.
 
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.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Complaint handling and capa procedures.
 
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Brand Name
ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVICE
Type of Device
DEVICE, CYSTOMETRIC, HYDRAULIC
Manufacturer (Section D)
CONVATEC INC.
211 american ave.
greensboro NC 27409
Manufacturer Contact
matthew walenciak, int, ass dir
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key3908217
MDR Text Key4583122
Report Number1049092-2014-00157
Device Sequence Number1
Product Code FEN
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/06/2014
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? Yes
Device Operator Health Professional
Device Model NumberABV301
Device Catalogue NumberABV301
Device Lot Number130745
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/06/2014
Initial Date FDA Received05/29/2014
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 Unknown
Patient Sequence Number1
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