TPRLC RASP PROV 6MM N/A 31-600309

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for TPRLC RASP PROV 6MM N/A 31-600309 manufactured by Biomet Uk Ltd..

MAUDE Entry Details

Report Number3002806535-2020-00126
MDR Report Key9810439
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-10
Date of Report2020-03-10
Date of Event2020-02-07
Date Mfgr Received2020-02-11
Date Added to Maude2020-03-10
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. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1BIOMET UK LTD.
Manufacturer StreetWATERTON INDUSTRIAL ESTATES
Manufacturer CityBRIDGEND CF313XA
Manufacturer CountryUK
Manufacturer Postal CodeCF31 3XA
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameTPRLC RASP PROV 6MM
Generic NameBONE RASP
Product CodeHTR
Date Received2020-03-10
Model NumberN/A
Catalog Number31-600309
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET UK LTD.
Manufacturer AddressWATERTON INDUSTRIAL ESTATES BRIDGEND CF313XA UK CF31 3XA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-10

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