FRAXEL RE:STORE LASER SYSTEM MCSR1500-D-INTL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-03-16 for FRAXEL RE:STORE LASER SYSTEM MCSR1500-D-INTL manufactured by Solta Medical, Inc..

Event Text Entries

[102626827] The product has been requested for evaluation however it has not yet been received.
Patient Sequence No: 1, Text Type: N, H10


[102626828] A patient's forehead, left arm and left thigh received treatment with a fraxel dual system on (b)(6) 2018. On (b)(6) 2018 the patient was treated with ointment for post traumatic atrophy scar. The symptoms are ongoing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011423170-2018-00024
MDR Report Key7345339
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-03-16
Date of Report2018-02-16
Date of Event2018-01-26
Date Mfgr Received2018-03-08
Date Added to Maude2018-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. JULI MOORE
Manufacturer Street3365 TREE COURT INDUSTRIAL BLV
Manufacturer CityST. LOUIS MO 63122
Manufacturer CountryUS
Manufacturer Postal63122
Manufacturer Phone6362263220
Manufacturer G1SOLTA MEDICAL
Manufacturer Street11720 N CREEK PARKWAY N STE 100
Manufacturer CityBOTHELL WA 98011
Manufacturer CountryUS
Manufacturer Postal Code98011
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFRAXEL RE:STORE LASER SYSTEM
Generic NamePOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
Product CodeONG
Date Received2018-03-16
Model NumberMCSR1500-D-INTL
ID NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSOLTA MEDICAL, INC.
Manufacturer Address11720 NORTH CREEK PKWY N SUITE BOTHELL WA 98011 US 98011


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-03-16

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