HEGAR 30-530

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-07-29 for HEGAR 30-530 manufactured by Miltex Instrument Co. Inc..

MAUDE Entry Details

Report Number2431021-1999-00004
MDR Report Key234961
Report Source05,06
Date Received1999-07-29
Date of Report1999-07-29
Date of Event1999-07-14
Date Mfgr Received1999-07-29
Date Added to Maude1999-08-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEGAR
Generic NameUTERINE DILATOR
Product CodeHDQ
Date Received1999-07-29
Model Number30-530
Catalog Number30-530
Lot NumberUNK
Device Eval'ed by MfgrR
Implant FlagN
Device Sequence No1
Device Event Key225724
ManufacturerMILTEX INSTRUMENT CO. INC.
Manufacturer Address700 HICKSVILLE RD. BETHPAGE NY 11714 US


Patients

Patient NumberTreatmentOutcomeDate
10 1999-07-29

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