MUELLER HAND BRACES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-16 for MUELLER HAND BRACES manufactured by Mueller.

Event Text Entries

[97715721] Braces were purchased today. They are not made by the manufacturer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5074602
MDR Report Key7199681
Date Received2018-01-16
Date of Report2018-01-12
Date of Event2018-01-12
Date Added to Maude2018-01-17
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
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMUELLER HAND BRACES
Generic NameHANDPIECE (BRACE)
Product CodeIQI
Date Received2018-01-16
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMUELLER


Patients

Patient NumberTreatmentOutcomeDate
10 2018-01-16

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