MACROPLASTIQUE IMPLANTS MPQ-2.5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-19 for MACROPLASTIQUE IMPLANTS MPQ-2.5 manufactured by Uroplasty, Llc.

MAUDE Entry Details

Report Number3002647932-2019-00004
MDR Report Key8807022
Date Received2019-07-19
Date of Report2019-07-18
Date of Event2019-01-07
Date Mfgr Received2019-07-02
Date Added to Maude2019-07-19
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 ContactMS. NICOLE BOSER
Manufacturer Street5420 FELTL ROAD
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal55343
Manufacturer Phone9524266141
Manufacturer G1UROPLASTY, LLC
Manufacturer Street5420 FELTL ROAD
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal Code55343
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMACROPLASTIQUE IMPLANTS
Generic NameMACROPLASTIQUE
Product CodeLNM
Date Received2019-07-19
Model NumberMPQ-2.5
Catalog NumberMPQ-2.5
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerUROPLASTY, LLC
Manufacturer Address5420 FELTL ROAD MINNETONKA MN 55343 US 55343


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-19

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