MOJI BACK 3007407687

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-26 for MOJI BACK 3007407687 manufactured by V2 Fitness, Llc.

Event Text Entries

[39683515] I became sick from side effect of meds, gained weight, shortness of breath, waking up in nightmare, dry cough, weakness, assault due to sleeplike state/numbness, unusual bleeding. I came to the emergency room at the (b)(6) complaining of stomach pain, got shot in stomach and i have not been right since, i cry a lot, feel movement inside of me, and get sick a lot, can't hold much food down. This was in (b)(6) 2015 or (b)(6) 2016, (b)(6) records. Tetra abdominal binder to help with bloating. Had trouble with equipment use, and when i would finish how long it took my blood pressure to be stable. Well i started having side effects and flashbacks after using some of my meds, nightmares, feeling like someone is taking advantage of me when i sleep, i am so used to working and living around other soldiers, loss of interest in work, i had no sex drive after use of some meds and experiencing ptsd, mst and depression, anxious. Reaction from stress test got sick and felt nauseous. I sought medical attention at the emergency room for chest pain and pain in my stomach. The attending physician told me that i had "some form of physical injury to my face, and chest, and that i "suffered from negative thoughts," and had reoccurring thoughts. " the attending physician also stated that i suffered from ptsd which was not being treated. I received several "blood test," i have requested, and i am still awaiting the receipt of the result(s) of those test. I am questioning how the drug "cocaine" was found in my urine as i am not now nor have i ever been a drug user. I believe that i could have possibly been the victim of a "date rape" drug, and i requested that a "rape test/examination" be performed, and my request was not honored.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5060596
MDR Report Key5469941
Date Received2016-02-26
Date of Event2015-01-01
Date Added to Maude2016-03-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
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 Sequence Number: 1

Brand NameMOJI BACK
Generic NameTHERAPEUTIC MASSAGER
Product CodeLYG
Date Received2016-02-26
Model Number3007407687
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerV2 FITNESS, LLC

Device Sequence Number: 2

Brand NameLIFESOURCE BLOOD PRESSURE MONITOR VA - 767 PLUS
Generic NameBLOOD PRESSURE MONITOR
Product CodeDXN
Date Received2016-02-26
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No2
Device Event Key0
ManufacturerA&D ENGINEERING INC.

Device Sequence Number: 3

Brand NameTETRA ABDOMINAL BINDER XL 42 4G
Generic NameTHERAPEUTIC MEDICAL BINDER
Product CodeFSD
Date Received2016-02-26
Model Number124114
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No3
Device Event Key0
ManufacturerTETRA MEDICAL SUPPLY CORP


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2016-02-26

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