MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-29 for HUMAN TOUCH, LLC manufactured by Human Touch, Llc.
[2127698]
Left leg trapped in zero gravity chair with no way to escape. Left leg pinned in between two levers on a zero gravity chair. Because of the design of the chair, there was no way to withdraw the leg without ripping it out and causing serious injury. Very dangerous product - life threatening. Saw dr (b)(6) on (b)(6) 2010. Diagnosed with a severe hematoma. My regular doctor in this group is dr (b)(6). Dr (b)(6) was not in the day i went in without an appointment. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021551 |
| MDR Report Key | 2188656 |
| Date Received | 2011-07-29 |
| Date of Report | 2011-07-21 |
| Date of Event | 2010-11-24 |
| Date Added to Maude | 2011-08-09 |
| 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 | 0 |
| 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 | HUMAN TOUCH, LLC |
| Generic Name | ZERO GRAVITY CHAIR |
| Product Code | ISA |
| Date Received | 2011-07-29 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUMAN TOUCH, LLC |
| Manufacturer Address | 3030 WALNUT AVE. LONG BEACH CA 90807 US 90807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2011-07-29 |