MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-01 for AMBER TEETHING NECKLACE manufactured by .
[122810908]
Amber teething necklaces, i have seen them on many infants and young toddlers. So i looked into them and they are marketed for babies. But the warning on age is hidden on most of the pages. So many do not see it unless you do some reading way down on the web page. I feel that they are putting children at risk because it is a hidden warning. I do not feel they should be misleading consumers on the dangers of this product and feel it should be removed or not be marketed for use on children. Product type: nursery equipment and supplies; brand name: many of them don't know all of them. Manufacturer: (b)(4) is just one of the few that market it for babies. Manufacturer website (b)(4); retailer state: online. Document number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080283 |
| MDR Report Key | 7926395 |
| Date Received | 2018-10-01 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-09-08 |
| 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 |
| 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 | AMBER TEETHING NECKLACE |
| Generic Name | RING, TEETHING NON-FLUID FILLED |
| Product Code | MEF |
| Date Received | 2018-10-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-01 |