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

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.

• Brand Name: FRAXEL RE:PAIR LASER SYSTEM
• Type of Device: NONE
• 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 Key: 1432727
• MDR Report Key: 1370589
• Event Key: 1307299
• Report Number: 2950711-2008-00001
• Device Sequence Number: 1
• Product Code: GEX
• 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 Received: 04/29/2009
• 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 Received: 11/06/2008
• 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

#	Treatment	Treatment Date
PREDNISONE
IMIQUIMOD
V-BEAM PDL