MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-01 for SESAME BEGINNINGS SB9698 manufactured by Bebe Toys Manufactury Ltd..
[122614660]
Paint from this teether came off in baby? S mouth. Product type: nursery equipment and supplies; manufacturer importer: regent baby products; additional details. Purchase date: (b)(6) 2018. Teether assortment sb9698; distributed by (b)(4). Document number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080253 |
| MDR Report Key | 7926059 |
| Date Received | 2018-10-01 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-09-16 |
| Date Added to Maude | 2018-10-02 |
| 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 | SESAME BEGINNINGS |
| Generic Name | RINGTEETHING NON-FLUID FILLED |
| Product Code | MEF |
| Date Received | 2018-10-01 |
| Model Number | SB9698 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEBE TOYS MANUFACTURY LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-01 |