MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for THE FIRST YEARS TEETHING RING manufactured by Learning Curve Brands, Inc., / Tomy International Inc. C/o Rc2 (h.k.) Ltd..
[122151611]
I work for a county health dept in (b)(6). I learned from a colleague that the (b)(6) county dept of health found that this product contains an internal part made with a high level of lead. When a young child puts this phone in the mouth (which is an intended, advertised feature of the product), saliva enters the holes in the "microphone" of the toy, contacts the lead component and gives the child a sweet sensation. The (b)(6) doh reports sending this finding to the cpsc over a year ago, based on analysis done by a cpsc-accredited laboratory. However, the product is still available to the public (see (b)(6) and other web sites). Incident location: (b)(6). Document number: (b)(4). Report number: (b)(4). Product description: the first years my phone musical toy: looks like a very simple cell phone with a soft teething ring around the perimeter. Investigators: (b)(6), dir, environmental health, (b)(6) county dept of health, (b)(6), cpsc report (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080104 |
| MDR Report Key | 7910122 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-09-06 |
| Date Added to Maude | 2018-09-26 |
| 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 |
| 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 | THE FIRST YEARS TEETHING RING |
| Generic Name | RING, TEETHING, NON-FLUID FILLED |
| Product Code | MEF |
| Date Received | 2018-09-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEARNING CURVE BRANDS, INC., / TOMY INTERNATIONAL INC. C/O RC2 (H.K.) LTD. |
| Manufacturer Address | 45 SHAWMUT RD CANTON MA 02021 US 02021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-25 |