MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-27 for PALISADES SWIVEL STOOL 867-28 manufactured by Nemschoff.
[58557550]
Patient Sequence No: 1, Text Type: N, H10
[58557551]
Nurse was sitting on the stool at the nurses station doing documentation/charting. The stool collapsed/fell apart while she was sitting on it. She fell onto the floor and fractured her tail bone. The post and seat detached from the base. The bolt that attaches the post to the base is very short. It looks like it is too short to adequately secure the post to the base. Manufacturer was notified and sent a technician to inspect and repair the stool. He replaced the original bolt with a longer bolt. The nurse weighs (b)(6). The stool has a weight capacity of 350 lbs (per manufacturer's specs).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6061737 |
| MDR Report Key | 6061737 |
| Date Received | 2016-10-27 |
| Date of Report | 2016-10-25 |
| Date of Event | 2016-10-12 |
| Report Date | 2016-10-25 |
| Date Reported to FDA | 2016-10-25 |
| Date Reported to Mfgr | 2016-10-25 |
| Date Added to Maude | 2016-10-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | PALISADES SWIVEL STOOL |
| Generic Name | STOOL, SWIVEL |
| Product Code | INM |
| Date Received | 2016-10-27 |
| Model Number | 867-28 |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEMSCHOFF |
| Manufacturer Address | 909 NORTH 8TH STREET SHEBOYGAN WI 53081 US 53081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-27 |