MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-16 for QUICKIE 2 LITE EIQ2N manufactured by Sunrise Medical Privada Misiones.
| Report Number | 9616084-2019-00009 |
| MDR Report Key | 9200192 |
| Date Received | 2019-10-16 |
| Date of Report | 2019-09-19 |
| Date of Event | 2019-09-13 |
| Date Mfgr Received | 2019-09-19 |
| Device Manufacturer Date | 2016-08-02 |
| Date Added to Maude | 2019-10-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GUSTAVO ZAMBRANO |
| Manufacturer Street | 2842 BUSINESS PARK AVE. |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal | 93727 |
| Manufacturer Phone | 5592942840 |
| Manufacturer G1 | SUNRISE MEDICAL PRIVADA MISIONES |
| Manufacturer Street | NO. 110 PRIVADA INDUSTRIAL MISIONES DE LAS CALIFORNIAS |
| Manufacturer City | TIJUANA, BAJA CALIFORNIA 22425 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | QUICKIE 2 LITE |
| Generic Name | MANUAL WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2019-10-16 |
| Model Number | EIQ2N |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL PRIVADA MISIONES |
| Manufacturer Address | NO. 110 PRIVADA INDUSTRIAL MISIONES DE LAS CALIFORNIAS TIJUANA, BAJA CALIFORNIA 22425 MX 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-10-16 |