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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RELIANT TECHNOLOGIES, INC.FRAXEL RE:PAIR LASER SYSTEMNONE

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RELIANT TECHNOLOGIES, INC. FRAXEL RE:PAIR LASER SYSTEM NONE   Back to Search Results
Event Date 05/09/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Patient experienced delayed wound healing and hyperkeratosis following a single treatment with the fraxel re:pair laser.

 
Manufacturer Narrative

Patient healed without dermal scarring or hypopigmentation, but still has textural irregularities on both cheeks. No device malfunction was associated with this event.

 
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Brand NameFRAXEL RE:PAIR LASER SYSTEM
Type of DeviceNONE
Manufacturer (Section F)
RELIANT TECHNOLOGIES, INC.
mountain view CA 94043
Manufacturer (Section D)
RELIANT TECHNOLOGIES, INC.
mountain view CA 94043
Manufacturer Contact
heather macfalls
464 ellis st.
mountain view , CA 94043
(650) 605 -2257
Device Event Key1432727
MDR Report Key1370589
Event Key1307299
Report Number2950711-2008-00001
Device Sequence Number1
Product CodeGEX
Report Source Manufacturer
Source Type Health Professional
Type of Report Initial
Report Date 11/06/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received11/06/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/29/2009 Patient Sequence Number: 1
#TreatmentTreatment Date
PREDNISONE
IMIQUIMOD
V-BEAM PDL
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