ARTHROSTIM INSTRUMENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-06 for ARTHROSTIM INSTRUMENT manufactured by Innovative Machinery Packaging And Converting Inc..

Event Text Entries

[49170582] Chiropractor (b)(6) used this on my neck. It felt like my cervical vertebrae were being pummeled. It strikes very hard and fast and my neck was hit with solid, hard plastic. It was way too much force on my cervical vertebrae. Afterwards my condition was worse. Chiropractor (b)(6) conducts his business from his property in a normal, isolated area at (b)(6), outside city limits. The instrument is mechanical and strikes really hard with a lot of force. I do not think chiropractors should be allowed to use this. They are not medical doctors. I have contacted the (b)(6) county sheriff's department. The reason i contacted law enforcement regarding this incident is because i told (b)(6) i did not want this instrument being used on me. He did not explain what the instrument was or where he was going to use it. The cervical vertebrae are not meant to take a lot of force. I have only heard of medical doctors using mechanized equipment to treat the cervical vertebrae - equipment i assume to have been approved by the fda. I had never heard of this equipment and he used it on my neck with way too much force. I feel he was trying to injure me. (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5063282
• MDR Report Key: 5778259
• Date Received: 2016-07-06
• Date of Report: 2016-06-27
• Date of Event: 2016-06-02
• Date Added to Maude: 2016-07-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ARTHROSTIM INSTRUMENT
• Generic Name: ARTHROSTIM INSTRUMENT
• Product Code: LXM
• Date Received: 2016-07-06
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INNOVATIVE MACHINERY PACKAGING AND CONVERTING INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2016-07-06