MalfunctionLQX
CHILDREN'S MEDICAL VENTURES
Received May 6, 2015 · Event occurred May 5, 2015
Report 4755195 · MDR key 4755195
Device
Generic name
Soothie Newborn Pacifier
Manufacturer
Philips Children's Medical VenturesModel number
*Catalog number
96004-N
Lot number
*
Product problems
- Device Dislodged or Dislocated
Patient
*
- No Information
Narrative
Description of Event or Problem
CONCERN FOR POTENTIAL HARM TO INFANT WHEN MEMBRANE ON PACIFIER COMES OUT (SMALL HOLE LOCATED IN MIDDLE OF PACIFIER DISLODGES). POTENTIAL FOR ASPIRATION.======================MANUFACTURER RESPONSE FOR SOOTHIE NEWBORN PACIFIER, CHILDREN'S MEDICAL VENTURES (PER SITE REPORTER).======================CONTACTED REP AND ORDER NUMBER WAS GIVEN.