InjuryFSQ
PALOMAR MEDILUX
Received Oct 5, 2004 · Event occurred Jan 10, 2004
Report MW1033394 · MDR key 557966
Device
Generic name
Intensed Pulsed Light
Manufacturer
Palomar Medical TechnologiesModel number
MEDILUXCatalog number
*
Lot number
*
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
33 YR
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
STARTING IN 2004 TO PRESENT, FACILITY HAS HAD -IPL- INTENSED PULSED LIGHT TREATMENTS FOR HAIR REMOVAL IN A SMALL AREA ON THE FACE. THEY NOW HAVE A LARGE AREA COVERING THE FACE WITH A HIGH VOLUME OF UNWANTED HAIR GROWTH THAT WAS NOT THERE PRIOR TO TREATMENTS. CALLED THE COMPANY & THEY SAID THIS HAS BEEN KNOWN TO HAPPEN. THE HEAT FROM THE IPL TRIGGERS SOMETHING IN THE LYMPHATIC SYSTEM & CAN CREATE MORE HAIR GROWTH, BUT THEY DID NOT HAVE TO DISCLOSE THIS TO PATIENTS BECAUSE IT DOES NOT ALWAYS HAPPEN.