MILTEX 76-70

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-02-18 for MILTEX 76-70 manufactured by Miltex Instrument Co., Inc..

Event Text Entries

[88453] Handle ring broke in several pieces in the doctors hand. Doctor cut palm of hand slightly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2431021-1998-00002
MDR Report Key150219
Report Source05
Date Received1998-02-18
Date of Report1998-02-13
Date of Event1998-02-10
Date Mfgr Received1998-02-13
Date Added to Maude1998-02-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMILTEX
Generic NameASPIRATING SYRINGE TYPE C-W
Product CodeEJI
Date Received1998-02-18
Model Number76-70
Catalog Number76-70
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key146365
ManufacturerMILTEX INSTRUMENT CO., INC.
Manufacturer Address6 OHIO DR-CB 5006 LAKE SUCCESS NY 110420006 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1998-02-18

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