MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for SAFETY 1ST ELLIE ELEPHANT TEETHER manufactured by Dorel Juvenile Inc..
[139555443]
When i went to wash my child's "safety 1st featuring mombella ellie elephant teether, blue, small," i discovered that the tip was almost completely bitten in half (but still attached) and one of the textured knobs was completely bitten off. I do not know if my child consumed the missing piece. This item poses a potential choking risk and should be recalled immediately. (b)(4). Purchase date: (b)(6) 2018. I still have the product for the purpose of inspection and reporting, but it is no longer being used. I have contacted the mfr and am awaiting a response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085059 |
| MDR Report Key | 8439769 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-02-26 |
| Date Added to Maude | 2019-03-21 |
| 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 | 3 |
| Brand Name | SAFETY 1ST ELLIE ELEPHANT TEETHER |
| Generic Name | RING, TEETHING, NON-FLUID FILLED |
| Product Code | MEF |
| Date Received | 2019-03-20 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DOREL JUVENILE INC. |
| Manufacturer Address | 1255 GREENE AVE STE 300 WESTMOUNT, QUEBEC H3Z 2A4 CA H3Z 2A4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-20 |