MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-03 for NUBY manufactured by Luv N' Care Ltd..
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I bought a vibrating teether for my son, after only 3 days of using it, it stopped vibrating. I opened up the back where the battery is to see if the battery maybe gotten moved, and it was full of corrosion. This is very unsafe for a baby to chew on. Incident location: (b)(6), united states; this is my home address. Retailer: (b)(6); retailer state: (b)(4); purchase date: (b)(6) 2018. Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078239 |
| MDR Report Key | 7663470 |
| Date Received | 2018-07-03 |
| Date of Report | 2018-06-11 |
| Date of Event | 2018-06-01 |
| Date Added to Maude | 2018-07-05 |
| 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 |
| 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, FLUID-FILLED |
| Product Code | KKO |
| Date Received | 2018-07-03 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUV N' CARE LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-03 |