MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-16 for SUPER SOOTHIE PACIFIER - OLDER THAN 3 MONTHS manufactured by Philips Children's Medical Ventures.
[1034998]
My son was getting fussy in his crib. My husband gave him a soothie pacifier, it claimed to be for babies older than 3 months to calm him and my husband went back to bed at 6:00 am. Within a few minutes, we heard our son screaming. My husband went into our son's room to bring him to me. I discovered that somehow the entire soothie pacifier was lodged in his mouth. There was nothing showing of the pacifier, but my son's mouth could not shut. My son had vomited enough to get has crib sheets and his pajamas thoroughly wet. I quickly removed the pacifier from his mouth. Luckily, my son did not choke on his vomit or suffocate. Dates of use: 2008. Diagnosis or reason for use: calm a fussy baby. Event abated after use stopped: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009664 |
| MDR Report Key | 1293899 |
| Date Received | 2009-01-16 |
| Date of Report | 2009-01-16 |
| Date of Event | 2008-12-26 |
| Date Added to Maude | 2009-02-03 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER SOOTHIE PACIFIER - OLDER THAN 3 MONTHS |
| Generic Name | NONE |
| Product Code | LQX |
| Date Received | 2009-01-16 |
| Model Number | SUPER SOOTHIE |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS CHILDREN'S MEDICAL VENTURES |
| Manufacturer Address | 191 WYNGATE DRIVE MONROEVILLE PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-01-16 |