MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-17 for ZIPPIE VOYAGE EIZ16 manufactured by Sunrise Medical Privada Misiones.
| Report Number | 9616084-2019-00010 |
| MDR Report Key | 9203836 |
| Date Received | 2019-10-17 |
| Date of Report | 2019-09-23 |
| Date of Event | 2019-09-20 |
| Date Mfgr Received | 2019-09-23 |
| Device Manufacturer Date | 2019-07-22 |
| Date Added to Maude | 2019-10-17 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZIPPIE VOYAGE |
| Generic Name | STROLLER (CHAIR WITH CASTERS) |
| Product Code | INM |
| Date Received | 2019-10-17 |
| Model Number | EIZ16 |
| 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 | 2019-10-17 |