MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-15 for TDX SP2 BASE FOR REHAB SEATING NA:TDXSP2 TDXSP2 manufactured by Invacare Taylor Street.
[175089123]
This record is being filed in an abundance of caution. At the time of this filing, no malfunctions or deficiencies have been alleged. Invacare was made aware of this event that occurred in (b)(6) with a tdx-sp2-nb wheelchair. This record was created due to the u s. Manufactured tdxsp2 being similar in design and would likely to have the same adverse outcome as this event. The tdx-sp2-nb wheelchair has not been returned to invacare (b)(4) for an evaluation.
Patient Sequence No: 1, Text Type: N, H10
[175089124]
The end user, was riding on a tram which braked suddenly. The wheelchair slid forward, causing the end-user to hit a metal bar, breaking their teeth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2020-00006 |
| MDR Report Key | 9592393 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-16 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-01-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE TAYLOR STREET |
| Manufacturer Street | 1200 TAYLOR STREET |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDX SP2 BASE FOR REHAB SEATING |
| Generic Name | WHEELCHAIR, POWERED |
| Product Code | ITI |
| Date Received | 2020-01-15 |
| Model Number | NA:TDXSP2 |
| Catalog Number | TDXSP2 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE TAYLOR STREET |
| Manufacturer Address | 1200 TAYLOR STREET ELYRIA OH 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-15 |