HALL LARGE BONE OSCILLATING BLADE 00507158200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,08 report with the FDA on 2007-11-30 for HALL LARGE BONE OSCILLATING BLADE 00507158200 manufactured by Conmed Linvatec.

Event Text Entries

[766632] It was reported by our distributor in japan that the package containing this sterile blade has a crack in the tray.
Patient Sequence No: 1, Text Type: D, B5


[7895378] No medwatch form received from the user facility. Investigation results: the device was received for evaluation. A visual inspection found no damage to the outer box containing this product but found a crack/hole in the corner of the blister package which contains the blade. Further investigation found that the sterility of the product is compromised. A review of product history for the past 2 years found no other similar reports for this problem. There is one other reported problem for this lot number and blade packaged in the same box. This blade is sold sterile, in a box of 5.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1017294-2007-00829
MDR Report Key956749
Report Source00,01,08
Date Received2007-11-30
Date of Report2007-11-02
Date Mfgr Received2007-11-02
Device Manufacturer Date2007-08-01
Date Added to Maude2008-03-13
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 FDA0
Event Location0
Manufacturer ContactBEVERLY SCHANER
Manufacturer Street11311 CONCEPT BLVD.
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal33773
Manufacturer Phone7273995169
Manufacturer G1CONMED LINVATEC
Manufacturer Street11311 CONCEPT BLVD.
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal Code33773
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHALL LARGE BONE OSCILLATING BLADE
Generic NameOSCILLATING BLADE
Product CodeDZH
Date Received2007-11-30
Returned To Mfg2007-11-28
Model NumberNA
Catalog Number00507158200
Lot NumberBBD24642
ID NumberNA
Device Expiration Date2012-08-31
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key953431
ManufacturerCONMED LINVATEC
Manufacturer AddressLARGO FL US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-11-30

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