MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for SILICONE BABY TEETHING TOY INFANT RATTLING TEETHER SOOTHING PANDAMELON manufactured by Unk.
[185189078]
On (b)(6) 2020, there is a little white bait with a hole at the bottom. There is a plastic round ball about the size of a marble and the consumer said that her husband was able to pop the ball out. Therefore, it could be a choking hazard. The baby was chewing on the toy, but was not injured. The diameter of the ball popped out is slightly larger than a dime, but smaller than a nickel. The consumer called (b)(6) and reported her concerns. The rep told her that they would notify the seller. The consumer contacted the fda, because she claims that the product was fda approved. The fda said that they don't approve toys and referred her to cpsc. Retailer: (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093921 |
| MDR Report Key | 9877805 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-19 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| 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 | 3 |
| Brand Name | SILICONE BABY TEETHING TOY INFANT RATTLING TEETHER SOOTHING PANDAMELON |
| Generic Name | RING, TEETHING, NON-FLUID FILLED |
| Product Code | MEF |
| Date Received | 2020-03-24 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |