MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-16 for ZIPPIE VOYAGE EIZ14 manufactured by Sunrise Medical Privada Misiones.
[97474596]
Sunrise medical has requested with the dealer that the stroller be returned for a full evaluation. The stroller has the slide-n-lock base in which the seating system will slide onto the base and lock into place. The seating system is successfully locked in place when an audible click is heard. Past evaluations have found that if there is an obstruction, the slide-n-lock base and the seating system will not lock and the locking click will not be heard. A replacement stroller was shipped to the dealer on (b)(6) 2017. If there are any relevant findings from the evaluation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[97474597]
Per jp, the dealer, on (b)(6) 2017 while the child was at school the teacher was pushing the child around the corner and the seat slid off from the base with the child, hitting the ground. The child was taken to the hospital. The child allegedly has a chipped tooth and a "goose egg" (bump) on her forehead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616084-2018-00001 |
| MDR Report Key | 7197758 |
| Date Received | 2018-01-16 |
| Date of Report | 2018-03-16 |
| Date of Event | 2017-12-18 |
| Date Mfgr Received | 2018-02-20 |
| Device Manufacturer Date | 2017-07-05 |
| Date Added to Maude | 2018-01-16 |
| 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 |
| 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 | 2018-01-16 |
| Model Number | EIZ14 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Hospitalization | 2018-01-16 |