MAUDE Adverse Event Report: PEMF8000; PERIPHERALELECTROMAGNETIC FIELD

Model Number PEMF8000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Shock (2072)

Event Date 06/15/2017

Event Type  Injury  

Event Description

I sell many medical devices on my website (b)(6) and (b)(6) currently has offices in (b)(6) i purchased a pemf8000 from (b)(6) including pemf8000pro products.I thought this unit was fda approved and ul approved but now i find out it is not! while testing the unit i got such a shock that sent me to the floor.This is a very dangerous unit and they are selling to chiropractors who don't know how dangerous it is.I feel their pts are in great danger.Please look into this immediately, at least put a freeze on their websites pending your investigation.I have included their info below.(b)(6).

• Brand Name: PEMF8000
• Type of Device: PERIPHERALELECTROMAGNETIC FIELD
• MDR Report Key: 6685950
• MDR Text Key: 79240688
• Report Number: MW5070780
• Device Sequence Number: 1
• Product Code: MBQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: PEMF8000
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR
• Patient Weight: 84