PRO-ADJUSTER, ACCUWAVE, SMART ADJUSTER -SA201-

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-17 for PRO-ADJUSTER, ACCUWAVE, SMART ADJUSTER -SA201- manufactured by .

Event Text Entries

[1142169] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5010825
• MDR Report Key: 1366575
• Date Received: 2009-04-17
• Date of Report: 2009-04-17
• Date of Event: 2009-03-23
• Date Added to Maude: 2009-05-12
• 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: 3
• Reporter Occupation: PATIENT
• 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: PRO-ADJUSTER, ACCUWAVE, SMART ADJUSTER -SA201-
• Generic Name: PRO-ADJUSTER
• Product Code: LXM
• Date Received: 2009-04-17
• Model Number: PRO-ADJUSTER
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention; 2. Deathisabilit	2009-04-17