STIM-U-DENT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-14 for STIM-U-DENT * manufactured by Johnson & Johnson Consumer Product, Inc..

Event Text Entries

[49604] The product splinters and breaks off when used as directed. The rptr is concerned that a pt could swallow or choke. He also feels that if pieces of the product got caught in the gums, it could cause infection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4001806
MDR Report Key76548
Date Received1997-03-14
Date of Report1997-03-10
Date Added to Maude1997-03-19
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 NameSTIM-U-DENT
Generic NameINTERDENTAL STIMULATOR
Product CodeJET
Date Received1997-03-14
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key76272
ManufacturerJOHNSON & JOHNSON CONSUMER PRODUCT, INC.
Manufacturer AddressRANDVIEW RD SKILLMAN NJ 08558 US


Patients

Patient NumberTreatmentOutcomeDate
10 1997-03-14

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