ENDERMOLOGIE MACHINE
Received May 11, 2000 · Event occurred Mar 1, 2000
Report MW4002768 · MDR key 278578
Device
Generic name
Endermologie Machine
Manufacturer
Lpg Usa, Inc.Model number
NICatalog number
NI
Lot number
UNK
Product problems
- False claim
Patient
NO INFO
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
CONSUMER REPORTED THAT THEY SAW NO RESULTS AFTER HAVING TREATMENTS TO REDUCE CELLULITE. CONSUMER EXPLAINED THAT THEY HAD THE FIRST OF 15 ENDERMOLOGIE TREATMENTS. THEY EXPLAINED THE TREATMENTS AS FOLLOWS: AN ENDERMOLOGIE MACHINE WHICH HAS TWO ROLLERS WITH SUCTIONS ROLLED OVER THE LEGS. THE SUCTIONS LIFT UP THE SKIN AND MASSAGE IT, SIMILAR TO DEEP TISSUE MASSAGE. THIS IS SUPPOSED TO BREAK UP THE FAT AND REDUCE CELLULITE. CONSUMER'S TREATMENT CONSISTED OF TWO TREATMENTS EACH WEEK FOR 7 WEEKS. THE MANAGER OF THE FACILITY WHERE CONSUMER HAD THE TREATMENTS TOLD THEM THE CELLULITE WAS NOT REMOVED BECAUSE CONSUMER DID NOT DRINK ENOUGH WATER. CONSUMER ALSO SAID THE ADVERTISEMENTS IN THE LOCAL NEWSPAPERS AND PHONE BOOKS STATE THAT THE ENDERMOLOGIE MACHINES ARE FDA APPROVED.