MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-06 for PHILIPS SOOTHIE PACIFIER manufactured by Philips Healthcare.
[18274937]
I used philips brand soothie pacifiers for my child. They were given to me by the nicu at our (b)(6) hospital in 2010. A year later (they are no longer being used), i noticed that one of the pacifiers within a group of a half dozen was sticky/greasy on all surfaces. The pacifier had been stored in an open glass container and used constantly for 6 months. It was only ever washed by hand. My child has not gotten visible ill from using the pacifier, but i am deeply concerned that she has ingested the plasticizer found on the pacifier. Dates of use: (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023914 |
| MDR Report Key | 2426079 |
| Date Received | 2011-12-06 |
| Date of Report | 2011-12-06 |
| Date of Event | 2011-06-23 |
| Date Added to Maude | 2012-01-26 |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS SOOTHIE PACIFIER |
| Generic Name | PACIFIER |
| Product Code | LQX |
| Date Received | 2011-12-06 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-06 |