ORAFIX SPECIAL DEN. ADHESIVE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-30 for ORAFIX SPECIAL DEN. ADHESIVE * manufactured by Hogil Pharmaceutical Corp..

Event Text Entries

[20684334] Rptr telephoned smithkline beecham, and was informed that this product was sold to hogil pharmaceutical corp. On april 1, 1996 and that they were now the mfr. The rptr has 2 questions. Who manufactures this product? What are the ingredients?
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1012429
MDR Report Key130354
Date Received1997-10-30
Date of Report1997-10-29
Date of Event1997-06-01
Date Added to Maude1997-11-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameORAFIX SPECIAL DEN. ADHESIVE
Generic Name*
Product CodeKOQ
Date Received1997-10-30
Model Number*
Catalog Number*
Lot Number70313
ID Number*
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key127482
ManufacturerHOGIL PHARMACEUTICAL CORP.
Manufacturer Address1 BYRMBROOK PL. ARMONK NY 1050 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-10-30

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