MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-20 for TDX SP2 BASE FOR MULTIPLE ACTUATOR SYSTEM W/ ULTRA LOW MAXX NA:TDXSP2-MCG TDXSP2-MCG manufactured by Invacare Taylor Street.
[176382543]
The patient called to report an issue with her wheelchair that happened several months ago. The end user claims she stopped the chair on the ramp and it slid on the ramp a small amount of space. The end user was unsure if brakes were on, or if wheels turned when the wheelchair slid. There is no part to return as the product was repaired several months ago. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[176382544]
The patient reported that on (b)(6) 2019, she was coming out of her van, and the tdxsp2 wheelchair slid forward, and she fell out. She was not wearing the seat positing strap, due to it being broken previously. She hit her head, and banged up her nose, mouth, and leg. She went to the er and received cream for the scrapes. A few days later she went back to the er, where they prescribed antibiotics, due to the scratches on her leg got infected and she noticed her leg was swollen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2020-00007 |
| MDR Report Key | 9607875 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-20 |
| Date of Report | 2019-12-18 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2018-05-01 |
| Date Added to Maude | 2020-01-20 |
| 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 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| 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 MULTIPLE ACTUATOR SYSTEM W/ ULTRA LOW MAXX |
| Generic Name | WHEELCHAIR, POWERED |
| Product Code | ITI |
| Date Received | 2020-01-20 |
| Model Number | NA:TDXSP2-MCG |
| Catalog Number | TDXSP2-MCG |
| 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. Required No Informationntervention | 2020-01-20 |