MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-02-04 for SUPERSTAND HPS-2 manufactured by The Standing Company.
[3286694]
The customer called in on (b)(6) 2012 and said he fell out of his wheelchair around (b)(6). Customer had been using the stand up wheelchair since (b)(6) 2012 (3 months). Customer said he leaned over to pick up keys off the floor and fell out of his chair when the wheelchair rose up as he shifted his weight off the seat because he didn't bring it down to the locked position. Customer got back in the chair and continued with his day. He did not think it was a big deal. Customer did not seek medical care nor see a doctor until two weeks later. The doctor identified a fracture of the leg and advised customer to stay off his leg for a month or so until it healed. The customer notified the standing company on (b)(6) 2013 that his leg has not healed properly and that further medical attention may be necessary. We are currently awaiting for any medical updates.
Patient Sequence No: 1, Text Type: D, B5
[10469735]
Manufacturer has reviewed safe operating procedures (sops) with customer again. Customer acknowledges his wheelchair was not down totally in the fail-safe position. Manufacturer updated the safe operating procedures on 12/13/2012. (s. O. P. ) rule #1, now reads: before transferring in or out of the chair or before bending over to reach the floor... I must make sure the safety lock is on (that is, chair is in full down position - with raise levers all the way to the rear). (s. O. P) rule #17, i understand superstand must be completely down before transferring out. (listen for click and clunk when raise levers go all the way to the rear).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007494904-2013-00001 |
| MDR Report Key | 2949526 |
| Report Source | 04 |
| Date Received | 2013-02-04 |
| Date of Report | 2013-02-04 |
| Date of Event | 2012-11-22 |
| Date Mfgr Received | 2012-12-07 |
| Device Manufacturer Date | 2012-08-26 |
| Date Added to Maude | 2013-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 5848 DIXIE HIGHWAY |
| Manufacturer City | SAGINAW MI 48601 |
| Manufacturer Country | US |
| Manufacturer Postal | 48601 |
| Manufacturer Phone | 9897469100 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERSTAND |
| Generic Name | STAND UP WHEELCHAIR |
| Product Code | IPL |
| Date Received | 2013-02-04 |
| Model Number | HPS-2 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE STANDING COMPANY |
| Manufacturer Address | SAGINAW MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-04 |