INDIANA TOME 200060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-05-07 for INDIANA TOME 200060 manufactured by Biomet, Inc..

Event Text Entries

[19487794] During carpal tunnel release performed in 1999 patient sustained partial median nerve laceration. Surgery to repair median nerve was performed 3 days later.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825034-2002-00046
MDR Report Key392263
Report Source00
Date Received2002-05-07
Date of Report2002-05-03
Date of Event1999-02-22
Date Facility Aware2002-05-03
Report Date2002-05-03
Date Mfgr Received2002-04-04
Date Added to Maude2002-05-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBETH ALBERT, AST.
Manufacturer StreetP.O. BOX 587
Manufacturer CityWARSAW IN 465810587
Manufacturer CountryUS
Manufacturer Postal465810587
Manufacturer Phone5742676639
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameINDIANA TOME
Generic NameINSTRUMENT, MANUAL, SURGICA
Product CodeEKD
Date Received2002-05-07
Model NumberNA
Catalog Number200060
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key381290
ManufacturerBIOMET, INC.
Manufacturer AddressPO BOX 587 WARSAW IN 465810587 US
Baseline Brand NameINDIANA TOME
Baseline Generic NameINSTRUMENT, MANUAL, SURGICA
Baseline Model NoNA
Baseline Catalog No200060
Baseline IDNA
Baseline Device FamilyINDIANA TOME
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2002-05-07

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