MAUDE Adverse Event Report: CONVATEC INC. ABVISER® AUTOVALVE® IAP MONITORING DEVICE; DEVICE, CYSTOMETRIC, HYDRAULIC

Device Problem Deflation Problem (1149)

Patient Problem Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.A used device was returned for evaluation; however no model or lot number was available.The device was sent to the manufacturer for evaluation.No additional details or patient data have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on march 02, 2016.(b)(4).

Event Description

It was reported that the device failed to deflate.There was one (1) liter of urine found in the patient's bladder, when the issue was noticed.No lab test were conducted.The bladder was drained without issue after the device was discontinued.Additional information was received on (b)(6) 2016, noting that the patient had a blood clot that formed right at the abviser balloon and was clotted off and there was no device malfunction noted.There was no patient harm reported.

Manufacturer Narrative

The complaint sample was returned however, an evaluation was not performed and is pending.Once the investigation is complete, a follow-up report will be submitted.No additional details or patient data have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: ABVISER® AUTOVALVE® IAP MONITORING DEVICE
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5475048
• MDR Text Key: 39519264
• Report Number: 1049092-2016-00073
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention