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

Model Number ABV601

Device Problem No Flow (2991)

Patient Problem Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

Initial emdr is being re-submitted per request of fda on 29-apr-2021.Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4) pro and protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filling 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 1722554-2015-31258.The correct manufacturers report number should have been 1049092-2015-31258.In addition, field manufacturer has been updated to reflect this correction.Please note, field mfr site has also been updated.(b)(4).

Event Description

The customer reported that on couple of occasions, autovalve failed to do it's work and resulted in retention of fluid in patient's bladder.On one occasion, it resulted in retention of 1.5l of fluid, which nearly caused serious complications.

• Brand Name: ABVISER AUTOVALVE IAP MONITORING DEVICE, 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: 5309698
• MDR Text Key: 250915261
• Report Number: 1049092-2015-31258
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• 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 Expiration Date: 05/17/2015
• Device Model Number: ABV601
• Device Lot Number: 120529
• 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
• Date Device Manufactured: 05/17/2012
• 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