FRAXEL LASER RESURFACING RESTORE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-25 for FRAXEL LASER RESURFACING RESTORE manufactured by Solta Medical, Inc..

MAUDE Entry Details

Report NumberMW5090044
MDR Report Key9124002
Date Received2019-09-25
Date of Report2019-09-23
Date of Event2018-03-13
Date Added to Maude2019-09-26
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 NameFRAXEL LASER RESURFACING RESTORE
Generic NamePOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM / FRACTIONAL OUTPUT
Product CodeONG
Date Received2019-09-25
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSOLTA MEDICAL, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit 2019-09-25

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