PELVILACE? BIOURETHRAL SUPPORT SYSTEM 482150

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 2016-11-04 for PELVILACE? BIOURETHRAL SUPPORT SYSTEM 482150 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[59174027] November 2016 quarterly asr report (b)(4). The total number of events for product classification code pag is (b)(4). Qty 13-pelvilace biourethral support system 2 needle introducers, 1 disposable handle. 4 tissue connectors, 1. 5cm x 50cm porcine acellular collagen matrix sling. Qty 3- pelvilace to biourethral support system needle and implant halo needle 50cm. Qty 7- pelvilace to biourethral support system needle and implant hook needle 50cm. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Sample not returned.
Patient Sequence No: 1, Text Type: N, H10


[59174028] November 2016 quarterly asr report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2016-01559
MDR Report Key6078973
Report SourceOTHER
Date Received2016-11-04
Date of Report2017-09-22
Date Mfgr Received2016-09-13
Date Added to Maude2016-11-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationATTORNEY
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 UNIT 1
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePELVILACE? BIOURETHRAL SUPPORT SYSTEM
Generic NamePELVILACE? BIOURETHRAL SUPPORT SYSTEM
Product CodePAG
Date Received2016-11-04
Catalog Number482150
Lot NumberBMWC0013
Device Expiration Date2014-04-30
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD UNIT 1 COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-11-04

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