inforMED
MalfunctionMEF

BORN FREE GUM BRUSH TEETHER

Received Dec 1, 2011 · Event occurred Nov 2, 2011

Report MW5023295 · MDR key 2359417

Device

Generic name

Teether

Catalog number

80527

Product problems

  • Detachment Of Device Component

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

NOTICED SOME OF THE SMALL "BRISTLES" ON BABY'S BLUE BORN FREE TEETHER WERE MISSING. I BRUSHED MY HAND OVER IT AND ANOTHER ONE FELL OUT. BABY LOVES CHEWING ON THIS TEETHER AND HAS PROBABLY INGESTED MISSING BRISTLES. I'M NOT SURE WHETHER OR NOT THAT IS SAFE (B)(4) BUT I WOULD ASSUME THIS ALSO COULD BE A CHOKING HAZARD. THIS IS A LINK TO THE PRODUCT, WHICH APPEARS TO HAVE BEEN DISCONTINUED: (B)(4). I CONTACTED BORN FREE / SUMMER INFANT WHO HAVE NOT ADDRESSED THE SITUATION. THIS WAS THE RESPONSE: THANK YOU FOR CONTACTING SUMMER INFANT, I HAVE ASKED THE APPROPRIATE MANAGER ABOUT THIS SITUATION AND HE HAS CONFIRMED THAT THE PRODUCT HAS PASSED ASTM CHILD SAFETY TESTS AND IS SAFE FOR YOUR CHILD. THANK YOU FOR YOUR TIME AND PATIENCE AND HAVE A GREAT DAY. (B)(4). BORN FREE GUM BRUSH TEETHER, BLUE CAN BE CHILLED OR FROZEN FOR CHILDREN (B)(6) MADE FROM (B)(6). PURCHASE DATE: (B)(6) 2011. THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: YES.