MICROAIRE ZB-214

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-21 for MICROAIRE ZB-214 manufactured by Microaire Surgical Instruments Llc.

MAUDE Entry Details

Report Number9354386
MDR Report Key9354386
Date Received2019-11-21
Date of Report2019-10-30
Date of Event2019-10-16
Report Date2019-10-30
Date Reported to FDA2019-10-30
Date Reported to Mfgr2019-11-21
Date Added to Maude2019-11-21
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICROAIRE
Generic NameBURR, ORTHOPEDIC
Product CodeHTT
Date Received2019-11-21
Model NumberZB-214
Lot Number1218334412
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMICROAIRE SURGICAL INSTRUMENTS LLC
Manufacturer Address3590 GRAND FORKS BLVD CHARLOTTESVILLE VA 22911 US 22911


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-21

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