MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-23 for TEETHING TOY manufactured by Tomy International, Inc..
[106591566]
Child chewing on teething toy - wire under rubbery surface broke through poking child in the mouth. Small wire could have been swallowed, as i could pull it out after taken from child. The wire is very sharp at both ends. I assume it broke at both ends. Nursery equipment and supplies. The first years learning curve? Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076647 |
| MDR Report Key | 7453683 |
| 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 | OTHER CAREGIVERS |
| 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 | TEETHING TOY |
| Generic Name | TEETHING RING |
| 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 | TOMY INTERNATIONAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-23 |