ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, POLE MOUNT ABV321

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-05 for ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, POLE MOUNT ABV321 manufactured by Wolfe Tory Medical Inc.

Event Text Entries

[30469681] Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4). 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).
Patient Sequence No: 1, Text Type: N, H10


[30469682] It was reported that nurse applied abvisor to end user and once placed noted crack in green diaphragm and leaking. Nurse removed abvisor and replaced with new abvisor.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1722554-2015-31259
MDR Report Key5204013
Date Received2015-11-05
Date of Report2014-02-27
Date of Event2012-12-07
Date Mfgr Received2014-02-27
Device Manufacturer Date2012-07-23
Date Added to Maude2015-11-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJEANETTE JOHNSON
Manufacturer Street211 AMERICAN AVE
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3362973009
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, POLE MOUNT
Generic NameDEVICE, CYSTOMETRIC, HYDRAULIC
Product CodeFEN
Date Received2015-11-05
Model NumberABV321
Lot Number120722
Device Expiration Date2015-07-23
OperatorNURSE
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWOLFE TORY MEDICAL INC
Manufacturer Address79 WEST 4500 SOUTH SUITE 18 SALT LAKE CITY UT 84107 US 84107


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-11-05

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