MAUDE MDR 1366575

MDR report key
1366575
Report number
MW5010825
Event key
0
Event type
3
Date of event
2009-03-23
Date received
2009-04-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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
1PRO-ADJUSTER, ACCUWAVE, SMART ADJUSTER -SA201-PRO-ADJUSTERLXMPRO-ADJUSTER N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-04-1701. R; 2. S

Event Narratives#

D

Patient 1

A DEVICE MADE BY SIGMA INSTRUMENTS WHICH IS MARKETED UNDER THE BRAND NAMES OF PRO-ADJUSTER, SPINELINER AND YP-412 IS USED BY CHIROPRACTORS TO MAKE ADJUSTMENT ON THE SPINE AND THE NECK. THE DEVICE IS POORLY DESIGNED AND POORLY MANUFACTURED AND AFTER I WAS ADJUSTED WITH THIS DEVICE, I HAD DIFFICULTY HEARING. I HAVE SINCE FOUND OUT THAT THE DEVICE HAS BEEN TESTED AND THE "IMPULSE HEAD" WHICH COMES INTO CONTACT WITH THE PATIENT'S BODY HAS A MEASURED NOISE OUTPUT OF 95DB. I HAVE ALSO LEARNED THAT A NOISE LEVEL THAT HIGH CAN CAUSE PERMANENT HEARING LOSS. THIS COMPANY ADVERTISES THAT IT HAS MORE THAN 5,000 MACHINES OPERATING IN DOCTOR'S OFFICES AND THIS PRODUCT IS NOT SAFE AND CAN CAUSE PERMANENT HEARING LOSS. I WAS ALSO TOUCHED BY THE "IMPULSE HEAD' DURING THE DOCTOR'S EXAMINATION AND I RECEIVED A BURNING "HEAT" PAIN BECAUSE THE IMPULSE HEAD GETS SO HOT. I FOUND THIS INFORMATION ABOUT THE MANUFACTURER: DEVICE NAME: PRO ADJUSTER.ACUWAVE.S.M.A.R.T.ADJUSTER. TYPE: ADJUSTING OR JOINT MOBILIZATION INSTRUMENT MANIPULATOR.PLUNGER-LIKE JOINT DEVICE CODE: LXM CATEGORY.