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

Model Number ABV321

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/17/2012

Event Type  malfunction  

Manufacturer Narrative

Initial emdr is being re-submitted per request of fda on 29-apr-2021.Reported to the fda on 04-nov-2015.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 1722554-2015-31261.The correct manufacturers report number should have been 1049092-2015-31261.In addition, field d3 has been updated to reflect this correction.Please note, field g1 has also been updated.Reported to the fda on 18-dec-2015.Fda registration number reporting site: (b)(4).Manufacturing site: (b)(4).

Event Description

The company representative reported that abviser inserted to a trauma patient, post splenectomy.Readings displayed varied considerably from those obtained prior to insertion; from teens down to 3.They tried troubleshooting and ultimately in less than 24 hours removed it and inserted another abviser.They felt readings were more aligned with their expectations.The patient was subsequently discharged from intensive care unit.No follow up information was available from that point.

• 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 NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 5309957
• MDR Text Key: 266976659
• Report Number: 1049092-2015-31261
• 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: ABV321
• 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
• Patient Age: 49 YR
• Patient Sex: Male