MAUDE Adverse Event Report: TETRA MEDICAL SUPPLY CORP TETRA ABDOMINAL BINDER XL 42 4G THERAPEUTIC MEDICAL BINDER

Model Number 124114

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: TETRA ABDOMINAL BINDER XL 42 4G
• Type of Device: THERAPEUTIC MEDICAL BINDER
• Manufacturer (Section D): TETRA MEDICAL SUPPLY CORP
• MDR Report Key: 5469941
• MDR Text Key: 39683515
• Report Number: MW5060596
• Device Sequence Number: 3
• Product Code: FSD
• 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: Other
• Device Model Number: 124114
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 02/26/2016 Patient Sequence Number: 1