*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-31 for * manufactured by Medel Development.

Event Text Entries

[819872] Mother of a child called to report that after 10 days using the device, her child chewed it, and it is unknown if the fragmented piece was swallowed or not. She stated that her child needs to wear this device 24 hr/day for 3-4 weeks to get the results which is to help her stop sucking.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5006049
MDR Report Key1021514
Date Received2008-03-31
Date of Report2008-03-31
Date Added to Maude2008-04-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameFINGER SUCKING DEVICE
Product CodeLQX
Date Received2008-03-31
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorOTHER
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key991066
ManufacturerMEDEL DEVELOPMENT
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2008-03-31

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