MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-28 for "SOOTHING AMBER" NECKLACES manufactured by .
[4657685]
Soothing amber necklaces are marketed to moms as a treatment for colic, teething etc. Any toy or jewelry or device that encircles an infant's or child's neck is inherently dangerous. I'm beginning to see these in my practice and it's only matter of time till a strangulation will occur. These things are new to me but are prevalent in the internet. Please look into these products. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036386 |
| MDR Report Key | 3845780 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-05-19 |
| Date of Event | 2014-05-15 |
| Date Added to Maude | 2014-06-04 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | "SOOTHING AMBER" NECKLACES |
| Generic Name | "SOOTHING AMBER" NECKLACES |
| Product Code | MEF |
| Date Received | 2014-05-28 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-28 |