MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-23 for SOPHIE LA GIRAFFE manufactured by Unk.
[106433969]
There was a small cut on sophie the giraffe's head. I paid no attention to this until i noticed small white pieces falling out. They are hard, like ceramic possibly. Not sure what this is. I noticed the cut prior to the pieces coming out. I informed the company. Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076671 |
| MDR Report Key | 7454157 |
| Date Received | 2018-04-23 |
| Date Added to Maude | 2018-04-24 |
| 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 | SOPHIE LA GIRAFFE |
| Generic Name | TEETHING TOY |
| Product Code | MEF |
| Date Received | 2018-04-23 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-23 |