UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-23 for UNK manufactured by .

Event Text Entries

[14868194] Stapectomy required due to loss of hearing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5007410
MDR Report Key1064738
Date Received2008-06-23
Date of Report2008-06-23
Date of Event2008-06-09
Date Added to Maude2008-06-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameSTAPES PROSTHESIS
Product CodeETB
Date Received2008-06-23
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date RemovedV
Device Sequence No1
Device Event Key1033551


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Deathisabilit 2008-06-23

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