I REST MASSAGER - MS TENS & PMS PROS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-02 for I REST MASSAGER - MS TENS & PMS PROS manufactured by Irest Health Science And Technology Co., Ltd..

Event Text Entries

[141016267] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085546
MDR Report Key8479564
Date Received2019-04-02
Date of Report2019-03-29
Date of Event2018-09-08
Date Added to Maude2019-04-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameI REST MASSAGER - MS TENS & PMS
Generic NameMASSAGER, THERAPEUTIC, ELECTRIC
Product CodeISA
Date Received2019-04-02
Model NumberPROS
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerIREST HEALTH SCIENCE AND TECHNOLOGY CO., LTD.


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-04-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.