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

Model Number ABV320

Device Problem No Flow (2991)

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

Event Type  Injury  

Manufacturer Narrative

Initial emdr is being re-submitted per request of fda on 27-apr-2021.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.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).On 17-dec-2015, the following correction was identified: the report submitted on 04-nov-2015, with the patient identifier (b)(6), had the incorrect manufacturer report number listed 1722554-2015-31255.The correct manufacturers report number should have been 1049092-2015-31255.In addition, mfr name has been updated to reflect this correction.Please note, mfr site has also been updated.(b)(4).

Event Description

The company representative reported that urinary auto valve did not drain the saline instilled in patient.The patient did not have any urine output.The staff believed the valve to be blocked.Discarded product and replaced with another.Not sure how long the valve was closed.The patient did not have adverse effects although a fluid bolus was given for decreased urine output.The patient was transferred to a long term acute care facility.

• Brand Name: ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, PATIENT MOUNT
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC,
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 5309995
• MDR Text Key: 263185527
• Report Number: 1049092-2015-31255
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: ABV320
• Device Lot Number: 10505A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 12/18/2015
• 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