MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for RED PATPAT PACIFIER manufactured by Ryan And Rose, Llc.
[138675574]
My (b)(6) bit through the patpat pacifier. The product was damaged before the incident: no. The product was modified before the incident: no. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084819 |
| MDR Report Key | 8413956 |
| Date Received | 2019-03-11 |
| Date of Report | 2019-02-12 |
| Date of Event | 2018-12-15 |
| Date Added to Maude | 2019-03-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 | RED PATPAT PACIFIER |
| Generic Name | RING, TEETHING, NON-FLUID FILLED |
| Product Code | MEF |
| Date Received | 2019-03-11 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RYAN AND ROSE, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-11 |