MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-16 for SUPERSTAND HPS-2 manufactured by The Standing Company.
[4461985]
On (b)(6) 2014, the standing company was notified by the case manager of the quadriparesis client that the client had been hospitalized. According to the case manager, the client said he was attempting to do push-ups (i. E. Strengthen his upper body and/or to provide relief to his skin) while in his wheelchair. The case manager said the client said he had his tibia supports on/installed, but did not have the armrest properly placed in front of him nor did he have his seat belt fastened. The case manager stated the client said as his chair started moving upward that "he (the client) panicked". He inadvertently leaned forward and grabbed for "something". The client said he then fell forward. The client broke his right tibia plateau (right lower leg near knee). The client, according ot the case manager was transported to a local hospital on (b)(6) 2014 and had surgery on both legs to stabilize the fracture. The client will then be in rehab facility for a length of time.
Patient Sequence No: 1, Text Type: D, B5
[12080583]
Based on what the case manager stated the client said, the standing company has attempted to duplicate client's problem but unable to do so. The standing company's service manager, a t-7 paraplegic who on a daily basis uses the exact same wheelchair the client uses, cannot - based on what the case manager stated the client said - recreate the incident. The case manager says she and the client - upon his return home - want tsc to (once again) provide the client with a refresher course regarding chair operation. We will comply. On (b)(4) 2014, a representative from the standing wheelchair company (tsc) visited with the wife of the client. During this time the representative of tsc inspected the chair. He drove chair and inspected the standing mechanism by going up and down in chair. He also assessed the armrest and the seatbelt for any issues. No issues were found. The evaluations deemed the chair to be fully functioning and in good working order.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007494904-2014-00001 |
| MDR Report Key | 3876255 |
| Report Source | 05 |
| Date Received | 2014-06-16 |
| Date of Report | 2014-06-11 |
| Date Mfgr Received | 2014-06-04 |
| Device Manufacturer Date | 2012-09-21 |
| Date Added to Maude | 2014-06-18 |
| 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 486010000 |
| Manufacturer Country | US |
| Manufacturer Postal | 486010000 |
| Manufacturer Phone | 9897469100 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERSTAND |
| Generic Name | STAND UP WHEELCHAIR |
| Product Code | IPL |
| Date Received | 2014-06-16 |
| Model Number | HPS-2 |
| ID Number | SJ0001 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization | 2014-06-16 |