MAUDE Adverse Event Report: V2 FITNESS, LLC MOJI BACK; THERAPEUTIC MASSAGER

Model Number 3007407687

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Dyspnea (1816); Hemorrhage/Bleeding (1888); Nausea (1970); Weakness (2145); Anxiety (2328); Depression (2361); Reaction (2414); Numbness (2415); Abdominal Distention (2601); Weight Changes (2607)

Event Date 01/01/2015

Event Type  Injury  

Event Description

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.

• Brand Name: MOJI BACK
• Type of Device: THERAPEUTIC MASSAGER
• Manufacturer (Section D): V2 FITNESS, LLC
• MDR Report Key: 5469941
• MDR Text Key: 39683515
• Report Number: MW5060596
• Device Sequence Number: 1
• Product Code: LYG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Device Operator: No Information
• Device Model Number: 3007407687
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 56 YR
• Patient Weight: 106