MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-19 for ZIPPIE VOYAGE EIZ14 manufactured by Sunrise Medical Privada Misiones.
[90777084]
A replacement stroller has been shipped to the dealer on 10/3/2017. Sunrise medical has requested with the dealer to ship the stroller back for an evaluation. A supplemental report will be filed with any relevant findings from the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[90777085]
Per dealer (b)(6) the seat is not locking into place. He states that the seat fell off. No injury occurred because the child was rear facing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616084-2017-00011 |
| MDR Report Key | 6963645 |
| Date Received | 2017-10-19 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-09-25 |
| Date Mfgr Received | 2017-09-25 |
| Device Manufacturer Date | 2016-09-08 |
| Date Added to Maude | 2017-10-19 |
| 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 | LBE |
| Date Received | 2017-10-19 |
| Model Number | EIZ14 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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 PARQUE INDUSTRIAL MISIONES DE LAS CALIFORNIAS TIJUANA, BAJA CALIFORNIA 22425 MX 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-19 |