FDA Adverse Event
Other
Summary report: N
PHILIPS SOOTHIE PACIFIER
MDR report key: 2426079
·
Received December 6, 2011
Report
- Report Number
- MW5023914
- Event Type
- Other
- Date Received
- December 6, 2011
- Date of Event
- June 23, 2011
- Report Date
- December 6, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- LQX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILIPS SOOTHIE PACIFIER | PACIFIER | LQX | PHILIPS HEALTHCARE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Other |