MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-23 for PACIFIER manufactured by Mam.
[81045236]
A (b)(6) month newborn sucking on pacifier when father noticed the pacifier looked funny. Took pacifier away from infant and noticed plastic nipple detached from plastic posing a high choking risk. Dates of use: (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071213 |
| MDR Report Key | 6740032 |
| Date Received | 2017-07-23 |
| Date of Report | 2017-07-23 |
| Date of Event | 2017-07-23 |
| Date Added to Maude | 2017-07-25 |
| 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 | PACIFIER |
| Generic Name | NIPPLE, LAMBS, FEEDING |
| Product Code | FNN |
| Date Received | 2017-07-23 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-23 |