MAUDE MDR 1272570

MDR report key
1272570
Report number
MW5009331
Event key
0
Event type
3
Date received
2008-12-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VIBEVIBE MACHINEHCC

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-12-160

Event Narratives#

D

Patient 1

I'M WRITING ABOUT THE CLASS 1 RECALL FOR VIBE TECHNOLOGIES. THE FDA INSTRUCTED VIBE TECHNOLOGIES TO INITIATE A RECALL OF 840 VIBE DEVICES. IN FACT, WHAT VIBE TECHNOLOGIES DID, WAS TO SEND OUT A "STICKER" TO ALL THE PEOPLE WHO PURCHASED A VIBE DEVICE, AND TOLD THEM TO PUT IT ON THEIR MACHINES. NOW, SAYS THE MFR, IT IS NO LONGER A "VIBE" MACHINE BUT IT IS NOW A "QUANTUM" SOMETHING OR OTHER! IT IS THE EXACT SAME MACHINE BUT THE PEOPLE WHO SELL TIME IN FRONT OF IT ARE NOW BEING TOLD TO ONLY SAY IT "ENERGIZES" AND NO LONGER THAT IT CURES CANCER ETC. THIS IS WRONG AND THE MFR IS TRYING TO SHORT -CIRCUIT THE LEGAL SYSTEM AND THE FDA WITH THIS BOGUS "CHANGE". FROM SOMEONE WHO OWNS A VIBE MACHINE: "WE NO LONGER OWN A VIBE MACHINE ... WE TRADED FOR A QUANTUM PULSE MACHINE, WHICH IS AN ENERGY ONLY DEVICE. WE HAVE ALREADY PAID ON IT ... I HAVE NO CHOICE BUT TO STAY OPTIMISTIC UNTIL WE GET THE SHAFT. SO FAR, THEY HAVE NOT RECALLED THE ACTUAL MACHINE, JUST MAKING PEOPLE BACKTRACK ON THE "HEALING" COMMENTS."