MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for NUBY manufactured by Unknown.
[136327631]
The bead of a nuby teething necklace broke at the manufactured seam when my toddler picked it up out of its box. It was straight out of the box and there were no notable causes to it breaking. My toddler wasn? T being rough with the necklace in any way. He just picked it up and the bead came off. This could have easily happened when a baby was chewing on the necklace (which is its intended use) and cause a life threatening chocking incident. There were no injuries sustained. I still have the necklace and have contacted the manufacturer. They want me to return the necklace. Product details: nuby tan and green teething necklace used for teething babies and worn by the mother. Purchased date: (b)(6) 2018. This date is an estimate. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083859 |
| MDR Report Key | 8320910 |
| Date Received | 2019-02-06 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-10-02 |
| Date Added to Maude | 2019-02-08 |
| 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 | NUBY |
| Generic Name | RING, TEETHING, NON-FLUID FILLED |
| Product Code | MEF |
| Date Received | 2019-02-06 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-06 |