MAUDE Adverse Event Report: IREST HEALTH SCIENCE AND TECHNOLOGY CO., LTD. I REST MASSAGER - MS TENS & PMS; MASSAGER, THERAPEUTIC, ELECTRIC

Model Number PROS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Anxiety (2328); Injury (2348); Test Result (2695)

Event Date 09/08/2018

Event Type  Injury  

Event Description

I purchased an "i rest massager" (ems, nems machine) at a trade show in (b)(6) on (b)(6) 2018 while i was in the city for the trade show.After reading through the manual / placement charts provided with the unit, and using for a while on my back, the brilliant idea came to me to try it out on my testes.After a review of the owner's manual and warnings, i falsely determined that there wasn't a risk with doing so.I used the unit in this way for 20 mins.The following morning when i woke up, i noticed that my testicles had diminished in size substantially and had no feeling.I monitored the situation for a day and then when back home in (b)(6), i visited my dr who asked to go for an ultrasound.After the ultrasound came back with no major defects, i continued to worsen in symptoms (both panic and depression set in as well as sexual symptoms).I spoke with another dr i knew and he said that he would recommend having my testosterone levels checked.My levels came back very low, at this time, i was put on testosterone replacement therapy for a short 3 wk cycle.After stopping the trt, my levels dropped again and slowly regained to near normal levels.I have been for many lab tests during this process and have now seen several drs, a urologist, and finally on (b)(6), an dendrochronologist.The urologist could not find any physical abnormalities and referred me to the endocrinologist.I went for a repeat ultrasound for the endocrinologist in (b)(6) which also showed no abnormalities.The endocrinologist informed me that in her opinion, the device possibly caused an acute injury that temporarily shut down my testes causing a severe drop in my testosterone levels resulting in the symptoms that i experienced.The endocrinologist believes that the symptoms of anxiety and stress that went along with this, prevented my testosterone levels from climbing back up quickly.I was on a trial of clomid which did increase my levels to well into the normal range.I am currently gradually ending my clomid use and will be completing lab work to find out my testosterone levels 1 month after being off clomid.The drs i have seen during this process have had a really hard time understanding how this device could have caused this injury and it has been questioned that it even did.Is it possible to find out if there have been similar cases caused by similar devices and what the injury / outcome was? distributed by (b)(4).

• Brand Name: I REST MASSAGER - MS TENS & PMS
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): IREST HEALTH SCIENCE AND TECHNOLOGY CO., LTD.
• MDR Report Key: 8479564
• MDR Text Key: 141016267
• Report Number: MW5085546
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PROS
• 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): Disability
• Patient Age: 32 YR
• Patient Weight: 86