MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-26 for HEAVY DUTY INVERSION TABLE 5177 manufactured by The Life Gear Company.
[1129642]
The inversion table my husband was using snapped at the weld of the main support section of the table while he was using it, causing the table to drop to the floor while he was upside down. The break was at the weld. When the weld snapped, it dropped straight down to the floor causing him to hit his head on the cement floor and it caused injury to his neck. This also caused the lever that releases your feet to become jammed and very difficult to get him out of that position. It is my understanding this company is out of business, yet their product still exists on the market. If i would not have been home, he could have died. This table is listed as medical equipment. Diagnosis or reason for use: used to stretch his spine and relieve pressure to his lower.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011236 |
| MDR Report Key | 1395105 |
| Date Received | 2009-05-26 |
| Date of Report | 2009-05-26 |
| Date of Event | 2009-04-30 |
| Date Added to Maude | 2009-06-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEAVY DUTY INVERSION TABLE |
| Generic Name | HEAVY DUTY INVERSION TABLE, 350 LB MAX. |
| Product Code | JFB |
| Date Received | 2009-05-26 |
| Model Number | 5177 |
| ID Number | S/N 150187517 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE LIFE GEAR COMPANY |
| Manufacturer Address | CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-05-26 |