inforMED

TIME MACHINE/ELECTRICAL STIMULATOR

Received Feb 1, 1994

Report MW4000134 · MDR key 11366

Product problems

  • Reaction

Patient

*

Narrative

Description of Event or Problem

SVC IS PROMOTED VIA TELEVISION. THE COMPLAINANT ALLEGES THAT AFTER USING THE SYSTEM 7 OR 8 TIMES, SHE BEGAN HAVING HAIR GROWTH ON HER FACE, WHEREEVER THE DEVICE WAS APPLIED. DEVICE IS AN ELECTRICAL STIMULATOR USED IN CONJUNCTION WITH A COLLAGEN QUENCHER. INSTRUCTIONS TELL YOU WHERE TO PLACE THE DEVICE ON YOUR FACE FOR A MINUTE AT A TIME CAUSING YOU TO FEEL A PULSING ELECTRICAL STIMULATION. THERE ARE APPROX 14 POINTS ON THE FACE. THE COMPLAINANT SAW HER DR WHO AT FIRST THOUGH IT WAS AN ALLERGIC REACTION. TESTS SHOWED NO ALLERGIC REACTION. A CHECK FOR HORMONAL IMBALANCE WAS NEGATIVE. COMPLAINANT SAID AFTER USING THE MACHINE SHE ALSO HAD TREMENDOUS PRESSURE ON HER FOREHEAD AND SHE FELT A BURNING OF THE MOUTH AND BODY.