MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-05 for STANDER BED RAIL ADVANTAGE TRAVELER BED RAIL ADVANTAGE TRAVELLER manufactured by Stander.
[35517222]
I bought stander's bed rail advantage traveler in the summer of 2011 from a local store, (b)(6), for my sister, (b)(6), who was a resident in an assisted living facility. On (b)(6) 2011, at approx 7 pm. (b)(6) tried to call the staff by reaching for a pull cord behind her bed. She lost her balance and slipped off the bed. (b)(6) head and right arm became wedged between her bed and the stander bed rail. (b)(6) was left suspended from her bed with her right arm extended outwards. (b)(6) was stuck entrapped for approx seven hours into the early hours of the next day. As a result of this incident, my sister suffered debilitating injuries, including a stress-induced heart attacked (aka "takosubo") and permanent paralysis, which eventually led to her death on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059075 |
| MDR Report Key | 5353532 |
| Date Received | 2016-01-05 |
| Date of Report | 2016-01-05 |
| Date of Event | 2011-12-22 |
| Date Added to Maude | 2016-01-08 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STANDER BED RAIL ADVANTAGE TRAVELER |
| Generic Name | STANDER BED RAIL ADVANTAGE TRAVELER |
| Product Code | FNJ |
| Date Received | 2016-01-05 |
| Model Number | BED RAIL ADVANTAGE TRAVELLER |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANDER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Deathisabilit | 2016-01-05 |