MAUDE Adverse Event Report: CONVATEC INC. ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, POLE MOUNT; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number ABV331

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro.Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).On (b)(6) 2015, the following correction was identified: the report submitted on (b)(6) 2015, with the patient identifier (b)(6), had the incorrect manufacturer report number listed (b)(4).The correct manufacturers report number should have been (b)(4).(b)(4).

Event Description

It was reported that diaphragm of abvisor was inflated by staff nurse and pressure monitored but then the diaphragm would not deflate.Abvisor removed and new one connected.

• Brand Name: ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, POLE MOUNT
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 5309713
• MDR Text Key: 263398528
• Report Number: 1049092-2015-31260
• 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
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABV331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• 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