MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-26 for REMOVAL OF BEDRAILS NONE manufactured by Unk.
[115487888]
Because of my fda rules to remove the rails from nursing home beds, my mother recently broke her leg in 2 places. She has had 6 surgeries on this leg and is now (b)(6). Now she has to suffer further with a broken leg. It wasn't bad enough that she is stuck in the nursing home but now i am greeted with why me questions, when it didn't need to be. What was the fda thinking, hospitals still have bed with rails. Her quality of life has gone downhill infinitely. Not every pt/resident should be as mom has stated: "i feel like i'm sleeping in a hole. " the situation the fda created is ludicrous as if everyone fits your square box in health issues, we dont and you need to reverse this action and add flexibility. The minute of my brother and i (guardian) saw this configuration we knew this would happen. It's too bad the fda didn't see forward past what a mistake, it really was.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078660 |
| MDR Report Key | 7725809 |
| Date Received | 2018-07-26 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-07-14 |
| Date Added to Maude | 2018-07-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | REMOVAL OF BEDRAILS |
| Generic Name | BED, MANUAL |
| Product Code | FNJ |
| Date Received | 2018-07-26 |
| Model Number | NONE |
| Catalog Number | NONE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | REMOVAL OF BEDRAILS |
| Generic Name | BED, MANUAL |
| Product Code | FNJ |
| Date Received | 2018-07-26 |
| Model Number | NONE |
| Catalog Number | NONE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-07-26 |