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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC, INC. ADVISER - INTRA ABDOMINAL PRESSURE MONITOR DEVICE; DEVICE, CYSTOMETRIC, HYDRAULIC
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CONVATEC, INC. ADVISER - INTRA ABDOMINAL PRESSURE MONITOR DEVICE; DEVICE, CYSTOMETRIC, HYDRAULIC Back to Search Results
Model Number ABV320
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2014
Event Type  malfunction  
Event Description
It was reported that the liquid is draining through the walls of the liquid return valve connected to the urinary catheter.
 
Manufacturer Narrative
Based on the available info, this event is deemed to be a reportable malfunction.No add'l pt/event details have been provided to date.Should add'l info become available, a f/u report will be submitted.
 
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Brand Name
ADVISER - 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,interim assoc d
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4373540
MDR Text Key5266567
Report Number1049092-2014-00663
Device Sequence Number1
Product Code FEN
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 11/27/2014
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 Expiration Date07/29/2016
Device Model NumberABV320
Device Lot Number130758
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/27/2014
Initial Date FDA Received12/29/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
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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