MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for BALTIC AMBER (CHERRY QUARTZ) ANKLETS SMALLEST SIZE OF 3 manufactured by Unk.
[131042883]
I heard that amber can be used as a natural pain reliever and anti inflammatory agent. Baltic amber necklaces, bracelets and anklets have been advertised and geared towards children to wear in place of talking over the counter pain meds. I ordered 2 small anklets on friday (b)(6) from the (b)(6) website and we received them in the mail on monday (b)(6). I removed the anklets from the packaging and placed them on my twin boy's ankles, using a twisting motion to properly secure the two ends. Not more than 5 mins had passed and the anklet was off my son's ankle and laying in the middle of the play mat and near his reach. Had i not been watching him, he could have easily swallowed and choked on the anklet. I immediately threw both anklets in the trash and contacted (b)(6). These pose am immediate choking risk and i am fortunate that i did not leave my boys unattended with the assumption that these anklets are safe. Document number: (b)(4). Report number: (b)(4). Retailer: (b)(6). Purchase date: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082304 |
| MDR Report Key | 8180948 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-02 |
| Date of Event | 2018-10-01 |
| Date Added to Maude | 2018-12-19 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | BALTIC AMBER (CHERRY QUARTZ) ANKLETS SMALLEST SIZE OF 3 |
| Generic Name | RING, TEETHING, NON-FLUID FILLED |
| Product Code | MEF |
| Date Received | 2018-12-19 |
| Device Availability | N |
| 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 | 2018-12-19 |