MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-11 for SAFARI FRIENDS manufactured by Nuby Loop / Luv N'care, Ltd..
[141916140]
This caller is reporting that she and her (b)(6) son were sitting together while he was chewing on his teething ring when he began crying. When she checked to see why he was crying, she discovered that the teething toy had turned in his mouth and was stuck. She removed the ring from his mouth as gently as possible and caused no injuries. Discomfort and a few moments of fear were the baby's trauma. She is reporting this incident as a precaution to other's to be aware of choking or injury while their child has this product. She has not contacted the mfr of this products. Retailer: gift. Retailer state: (b)(6). Purchase date: (b)(6) 2019, this date is an estimate. Document number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085805 |
| MDR Report Key | 8508986 |
| Date Received | 2019-04-11 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-04-01 |
| Date Added to Maude | 2019-04-12 |
| 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 | SAFARI FRIENDS |
| Generic Name | TEETHING RING NON-FLUID FILLED |
| Product Code | MEF |
| Date Received | 2019-04-11 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | NUBY LOOP / LUV N'CARE, LTD. |
| Brand Name | SAFARI FRIENDS |
| Generic Name | TEETHING RING NON-FLUID FILLED |
| Product Code | MEF |
| Date Received | 2019-04-11 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEWBY LOOP / LUV N'CARE, LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-11 |