MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-07-13 for SUPERSTAND HPS-2 manufactured by The Standing Company.
[6013042]
On (b)(6) 2015, patient (b)(6) female (b)(6) contacted tsc to advise she incurred an ankle injury. She received outpatient hospitalization to insert a plate and screws into her ankle. She is not certain when she incurred the injury as she is quadriplegic. Her interaction with tsc occurred 27 days earlier in the outpatient rehabilitation department of her local hospital on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
[14204519]
Patient said she thinks the break happened during her trial demonstration of standing wheelchair (four (4) weeks earlier), but she is not totally sure. Patient did not seem accusatory or upset during the conversation with her on (b)(6). Rather, patient seemed frustrated/depressed at this setback to the beginning of a standing program.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007494904-2015-00001 |
| MDR Report Key | 4914769 |
| Report Source | 00 |
| Date Received | 2015-07-13 |
| Date of Report | 2015-06-25 |
| Date of Event | 2015-05-29 |
| Date Mfgr Received | 2015-06-25 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2015-07-16 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERSTAND |
| Generic Name | STAND UP WHEELCHAIR |
| Product Code | IPL |
| Date Received | 2015-07-13 |
| Model Number | HPS-2 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2015-07-13 |