EXTRA HEAVY GREEN RUBBER DAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-03 for EXTRA HEAVY GREEN RUBBER DAM manufactured by Hygenic Corp..

Event Text Entries

[9812] Allergic reaction/contact dermatitis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4000171
MDR Report Key11390
Date Received1994-02-03
Date of Report1993-07-12
Date of Event1993-06-15
Date Added to Maude1994-02-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEXTRA HEAVY GREEN RUBBER DAM
Product CodeEIE
Date Received1994-02-03
Device Availability*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key11390
ManufacturerHYGENIC CORP.
Manufacturer AddressAKRON OH 44310 US


Patients

Patient NumberTreatmentOutcomeDate
10 1994-02-03

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