MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for TEETHING PRODUCT FILLED WITH GEL-LIKE BEADS, ELEPHANT SHAPE manufactured by Unk.
[107822507]
This product is a gel bead-filled teether. The beads started to come out. I kept the product to take photos and report it. I cannot find the product online. Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077078 |
| MDR Report Key | 7494397 |
| Date Received | 2018-05-07 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-04-25 |
| Date Added to Maude | 2018-05-08 |
| 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 | TEETHING PRODUCT FILLED WITH GEL-LIKE BEADS, ELEPHANT SHAPE |
| Generic Name | RING-TEETHING FLUID-FILLED |
| Product Code | KKO |
| Date Received | 2018-05-07 |
| Device Availability | Y |
| 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 | 2018-05-07 |