FRAXEL RE:STORE LASER SYSTEM SYS-SR1500-D-US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-05 for FRAXEL RE:STORE LASER SYSTEM SYS-SR1500-D-US manufactured by Solta Medical Inc.

Event Text Entries

[137874952] Product has not been returned. Additional event information has been requested, but not received. A review of the device history records is in progress. Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10


[137874953] A physician office representative reported that the patient developed blisters on their temple post treatment. Additional event information has been requested, but not received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011423170-2019-00028
MDR Report Key8392004
Report SourceHEALTH PROFESSIONAL
Date Received2019-03-05
Date of Report2019-02-07
Device Manufacturer Date2010-03-24
Date Added to Maude2019-03-05
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 ContactMS. JULI MOORE
Manufacturer Street3365 TREE CT INDUSTRIAL BLVD
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 Received2019-03-05
Model NumberSYS-SR1500-D-US
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSOLTA MEDICAL INC
Manufacturer Address11720 NORTH CREEK PKWY N SUITE 100 BOTHELL WA 98011 US 98011


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-03-05

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