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

Model Number ABV301

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

It is reported that after injection, for a while the auto valve was still closed and could not be opened automatically resulting in the device being removed because it could not be used in the pt.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There were no reports of the pt being harmed as a result of this malfunction.Additional quality info received on (b)(4) 2014 states that there were six (6) reported complaints appeared to be related to the autovalve.No additional pt/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.Reported to the fda on (b)(4) 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 ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, int asso dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4012684
• MDR Text Key: 4708419
• Report Number: 1049092-2014-00272
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Other
• Type of Report: Initial
• Report Date: 06/12/2014

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 Number: ABV301
• Device Catalogue Number: ABV301
• Device Lot Number: 11003D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2014
• Initial Date FDA Received: 07/07/2014
• 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