MAUDE Adverse Event Report: CONVATEC INC. ABVISER-INTRA ABD PRESSURE MONITOR DEVICE; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number ABV301

Device Problems Partial Blockage (1065); Obstruction of Flow (2423)

Patient Problems Urinary Retention (2119); Obstruction/Occlusion (2422)

Event Date 05/31/2014

Event Type  Injury  

Event Description

It is reported that while the device was in place related to a study at the institution on (b)(6) 2014; the absence of urine drainage in the collection bag was noticed on (b)(6) 2014.It is further reported that diuretic management was instituted with still no urine output; the abvisor was removed and immediately urine flow was reestablished and quantified 1800 cc.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Report states that the device was in use for two (2) days before the issue occurred.Additional quality evaluation performed on (b)(6) 2014 states that there are four (4) similar complaints noted for lack of urine flow with the device.No additional patient/event details have been provided to date.A report sample for evaluation is not expected.Should additional information become available.A follow-up report will be submitted.Reported to the fda on june 27, 2014.Convatec will continue to track and monitor such complaints according to convatec inc's.Complaint handling and capa procedures.

• Brand Name: ABVISER-INTRA ABD PRESSURE MONITOR DEVICE
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, int assoc dir ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3904191
• MDR Text Key: 16304907
• Report Number: 1049092-2014-00249
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ABV301
• Device Catalogue Number: ABV301
• Device Lot Number: 130932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2014
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR