MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for HOMBAE WOODEN TEETHER RINGS NATURAL WOOD TEETHING TOYS FOR INFANT, WOODEN TEETHE B077J2XH2H manufactured by Unk.
[137152280]
Package of wooden teething toys purchased from (b)(6). Package arrived and has labels. No origin or place of manufacturer. No company info or child safety tracking labeling, absolutely no labelling of any sort on or around product package besides upc. Title of product when purchased on (b)(6) is as follows "hombae wooden teether rings natural wood teething toys for infant, wooden teether animals for toddler, soothing pain relief toys for baby shower gift "called (b)(6) customer service to ask on safety of product they assured its safe but couldn't give any info on product or if it has any testing or certification. Product problem: unsafe size and shape for teething toys and children's toys. Sharp edges, small pieces, no warning with product included. Product is made from dry splintering wood. Purchase dates: (b)(6) 2018, the product was damaged before the incident: no, the product was modified before the incident? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084201 |
| MDR Report Key | 8359302 |
| Date Received | 2019-02-19 |
| Date of Report | 2018-12-29 |
| Date of Event | 2018-12-26 |
| Date Added to Maude | 2019-02-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | HOMBAE WOODEN TEETHER RINGS NATURAL WOOD TEETHING TOYS FOR INFANT, WOODEN TEETHE |
| Generic Name | RING, TEETHING, NON-FLUID FILLED |
| Product Code | MEF |
| Date Received | 2019-02-19 |
| Model Number | B077J2XH2H |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-19 |