VIBE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-16 for VIBE manufactured by .

Event Text Entries

[1021517] 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. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5009331
• MDR Report Key: 1272570
• Date Received: 2008-12-16
• Date of Report: 2008-12-16
• Date Added to Maude: 2009-01-13
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VIBE
• Generic Name: VIBE MACHINE
• Product Code: HCC
• Date Received: 2008-12-16
• Operator: OTHER
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-12-16