MUNCHABLES SENSORY STARLIGHT CHEWABLE NECKLACES FOR GIRLS (PURPLE/AQUA/PINK)
Received Jan 6, 2021 · Event occurred Nov 10, 2020
Report MW5098700 · MDR key 11131197
Device
Generic name
Ring, Teething, Non-fluid Filled
Manufacturer
MunchablesProduct problems
- Material Separation
Patient
7 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MY (B)(6) DAUGHTER HAS A NERVOUS HABIT OF CHEWING NONFOOD ITEMS. TO GIVE HER A SAFE OUTLET, WE BUY "(B)(6)" FOR HER TO CHEW. I RECENTLY PURCHASED HER THIS NECKLACE: (B)(6). IT IS ADVERTISED FOR "GIRLS" (IE NOT BABIES). FROM THE PRODUCT DESCRIPTION: "MUNCHABLES ARE SENSORY CHEWABLE JEWELRY THAT IS IDEAL FOR DIVERTING CHEWING FROM FINGERS, CLOTHING, HAIR, OR OTHER ITEMS. THE (B)(6) RECOGNIZES MUNCHABLES FOR THEIR ABILITY TO 'REPLACE INAPPROPRIATE CHEWING BEHAVIOR AND TO PROVIDE POTENTIAL REGULATING EFFECTS FOR THE SENSORY SYSTEM - REDUCING FIDGETING AND PROMOTING ATTENTION AND FOCUS.'" WITHIN LESS THAN 2 DAYS OF RECEIVING THE ITEM, MY DAUGHTER HAD CHEWED THROUGH THE LARGE SILICONE STAR AND HAD MOVED ON TO THE LITTLE BALLS, WHICH I STARTED FINDING ALL OVER THE HOUSE. THANK GOD SHE DIDN'T CHOKE ON THESE. WHEN I FORWARDED A PHOTO TO THE (B)(6) OWNER EXPRESSING MY CONCERNS THAT THESE ARE A SERIOUS CHOKING HAZARD AND ASKING THE PRODUCT TO BE REMOVED FROM (B)(6) SHE SAID THAT SHE KNOWS OF OTHER CHILDREN WHO HAVE HAD THIS ISSUE, BUT EXPRESSED NO WILLINGNESS TO REMOVE THE LISTING. SHE WANTED TO "MAKE IT RIGHT" BY SENDING MY DAUGHTER A FREE NECKLACE. I DON'T LIKE TO GET INVOLVED IN THIS SORT OF THING. HOWEVER, AS SHE IS CLEARLY NOT WILLING TO DO DUE DILIGENCE TO PREVENT A POSSIBLE CHOKING DEATH, I FEEL RESPONSIBLE TO REPORT THIS TO YOUR AGENCY IN THE HOPES OF GETTING THIS APPROPRIATELY ADDRESSED. I HAVE ALSO NOTICED THAT THIS MANUFACTURER HAS A WIDE VARIETY OF OTHER CHEWABLE NECKLACES AVAILABLE THAT SAME BALL-SHAPED BEADS WHICH POSED SUCH A HAZARD TO MY DAUGHTER. THANKS IN ADVANCE FOR YOUR CONSIDERATION OF THIS MATTER AND FOR EVERYTHING YOU DO TO PROTECT THE UC POPULATION FROM HARMFUL PRODUCTS. FDA SAFETY REPORT ID# (B)(4).