MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-01 for ZRA manufactured by Tisport, Llc.
[143807983]
We reviewed the dhr for this chair, and it passed all applicable quality tests and configuration requirements, and met specifications as ordered by the dealer when it left the facility. The dealer and/or a therapist measured the user for a wheelchair. Tisport as the manufacturer builds the chair based on the measurements provided to us from the dealer and/or therapist. All documentation and specifications for the chair were appropriately disseminated to the health specialist working with the end user. The device was not returned for evaluation. Based on the evidence provided, the fracture in the backrest bracket is likely the result of excessive forces introduced to the backrest assembly through impact or abuse. If more information is provided that changes the conclusions of the investigation, a follow up medwatch form 3500a will be filed.
Patient Sequence No: 1, Text Type: N, H10
[143807984]
The end user alleges that while putting on his pants in the bathroom, the backrest hinges fractured, resulting in ligament damage in his arm. He is in a full arm cast, and will receive injections in his arm as treatment with the possibility of surgery for future treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032618-2019-00004 |
| MDR Report Key | 8571403 |
| Report Source | CONSUMER |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-04-02 |
| Device Manufacturer Date | 2015-06-24 |
| Date Added to Maude | 2019-05-01 |
| 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. BRIAN ENGLISH |
| Manufacturer Street | 2701 W COURT ST |
| Manufacturer City | PASCO WA 99301 |
| Manufacturer Country | US |
| Manufacturer Postal | 99301 |
| Manufacturer Phone | 5095866117 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZRA |
| Generic Name | WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2019-05-01 |
| Model Number | ZRA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TISPORT, LLC |
| Manufacturer Address | 2701 W COURT ST PASCO WA 99301 US 99301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-01 |