MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-20 for IPLAY GREEN SPROUTS FLOWER RATTLE manufactured by I Play, Inc..
[117960393]
My (b)(6) son was chewing on the iplay green sprouts flower rattle (it's marketed as a chew / teething toy) when the light pink wooden circle on the pink flower came off. We found this part of the toy in his car seat and were very thankful he didn't choke on it while we were driving to an event. On (b)(6), there is another mother who cites the light pink circle and the silver rattle fell off. (b)(6). Incident location: other - (b)(6). Retailer, retailer state: (b)(6). The product was not damaged before the incident. Document number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079245 |
| MDR Report Key | 7801543 |
| Date Received | 2018-08-20 |
| Date of Report | 2018-08-06 |
| Date of Event | 2018-08-04 |
| Date Added to Maude | 2018-08-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | IPLAY GREEN SPROUTS FLOWER RATTLE |
| Generic Name | RING TEETHING NON-FLUID FILLED (GREEN SPROUTS) |
| Product Code | MEF |
| Date Received | 2018-08-20 |
| Model Number | FLOWER RATTLE |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | I PLAY, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-20 |