PPELVILACE? TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE 482151

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-06-26 for PPELVILACE? TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE 482151 manufactured by C.r. Bard, Inc. (covington) -1018233.

MAUDE Entry Details

Report Number1018233-2019-03392
MDR Report Key8736609
Report SourceOTHER
Date Received2019-06-26
Date of Report2019-06-26
Date Mfgr Received2019-06-11
Device Manufacturer Date2008-10-13
Date Added to Maude2019-06-26
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 ContactANGELA ROBINSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePPELVILACE? TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
Generic NamePELVILACE? TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
Product CodePAG
Date Received2019-06-26
Catalog Number482151
Lot NumberCVSJ0016
Device Expiration Date2010-04-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age3 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-26

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