MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-12 for AMBER TEETHING NECKLACE/JEWELRY manufactured by Unk.
[57369061]
Baby boy died using an amber teething necklace. It's a dangerous fad. These necklaces are sold everywhere, including (b)(6). For incident info, see (b)(6). It took place last week in (b)(6) at a childcare place. Please stop the sale of this "jewelry" for infants before more die. These teething necklace are marketed as a "teething aid. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065372 |
| MDR Report Key | 6027413 |
| Date Received | 2016-10-12 |
| Date of Report | 2016-10-12 |
| Date of Event | 2016-10-05 |
| Date Added to Maude | 2016-10-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| 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 | AMBER TEETHING NECKLACE/JEWELRY |
| Generic Name | TEETHING NECKLACE |
| Product Code | MEF |
| Date Received | 2016-10-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-10-12 |