MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-15 for VULLI SOPHIE THE GIRAFFE NEW BOX, POLKA DOTS manufactured by Vulli.
[102846713]
I had this sophie giraffe toy for my first child and let my second child, (b)(6)who is teething play with it in her crib. She was chewing on one of the feet when i walked out of the room. I left her alone for a few mins and came back, she had rolled onto her belly and the one leg was shoved all the way into her mouth down her throat. She was grasping for air and had thrown up all the contents of her belly on to her crib. Thank god i was only gone a couple mins. This thing is going in the garbage immediately. Not worth for your kids life. Should not be recommended for all ages. Incident location: (b)(6). Product type: toys. Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075915 |
| MDR Report Key | 7344801 |
| Date Received | 2018-03-15 |
| Date of Report | 2018-02-18 |
| Date of Event | 2018-01-03 |
| Date Added to Maude | 2018-03-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VULLI SOPHIE THE GIRAFFE NEW BOX, POLKA DOTS |
| Generic Name | RING, TEETHING, NON-FLUID FILLED |
| Product Code | MEF |
| Date Received | 2018-03-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VULLI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-15 |