MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for NUBY FRUITY VIBES VIBRATING TEETHER manufactured by Unk.
[145517901]
The nuby brand vibrating "fruity vibes" teether is dangerous. ((b)(4)); my friend's baby, who is (b)(6), is being treated because he was able to get the battery out and swallowed it. The parents are calling the company to report it. These should be recalled and no longer made. They have a button battery that can be life threatening. It even says on the packaging that it contains such a battery. Why would a company make a baby product that is to be chewed and used in an infant's mouth that contains a button battery that is known to be life threatening if swallowed? These need to be recalled. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086712 |
| MDR Report Key | 8620056 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-05-01 |
| Date Added to Maude | 2019-05-17 |
| 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 FRUITY VIBES VIBRATING TEETHER |
| Generic Name | RING, TEETHING, NON FLUID FILLED |
| Product Code | MEF |
| Date Received | 2019-05-16 |
| Device Availability | * |
| 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 | 2019-05-16 |