146-S MAPLE LEAF, SMALL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-11-21 for 146-S MAPLE LEAF, SMALL manufactured by Becker Orthopedic Appliance Co.

MAUDE Entry Details

Report Number1824252-2018-00002
MDR Report Key8095433
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2018-11-21
Date Mfgr Received2018-10-23
Date Added to Maude2018-11-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactERICA GUICE
Manufacturer Street635 EXECUTIVE DR
Manufacturer CityTROY MI 48083
Manufacturer CountryUS
Manufacturer Postal48083
Manufacturer Phone2485887480
Manufacturer G1BECKER ORTHOPEDIC APPLIANCE CO
Manufacturer Street635 EXECTUIVE DR
Manufacturer CityTROY MI 48083
Manufacturer CountryUS
Manufacturer Postal Code48083
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name146-S MAPLE LEAF, SMALL
Generic NameHIP ABDUCTION ORTHOSIS
Product CodeITS
Date Received2018-11-21
Model Number146-S
Catalog Number146-S
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECKER ORTHOPEDIC APPLIANCE CO
Manufacturer Address635 EXECTUIVE DR TROY MI 48083 US 48083


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-11-21

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