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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RELIANT TECHNOLOGIES, INC. FRAXEL RE:PAIR LASER SYSTEM NONE

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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  
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 D)
RELIANT TECHNOLOGIES, INC.
mountain view CA 94043
Manufacturer Contact
heather macfalls
464 ellis st.
mountain view , CA 94043
(650) 650 -6506
65060522 6506052257
MDR Report Key1370589
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
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
Type of Device Usage Reuse

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