inforMED
MalfunctionJET

SOFT-PICKS ADVANCED

Received Feb 16, 2026 · Event occurred Jan 19, 2026

Report 1413787-2026-00257 · MDR key 24343504

Device

Generic name

Pick, Massaging

Manufacturer

Sunstar Inc

Model number

6504R

Product problems

  • Break

Patient

NA · Unknown

  • Discomfort

Narrative

Description of Event or Problem

I AM WRITING TO FORMALLY COMPLAIN ABOUT A RECENT EXPERIENCE WITH YOUR GUM SOFT-PICKS. WHILE USING THE PRODUCT AS INTENDED, THE TIP SNAPPED OFF AND BECAME FIRMLY LODGED BETWEEN MY TEETH. AS SOMEONE WITH A VISUAL IMPAIRMENT, THIS SITUATION WAS INCREDIBLY STRESSFUL AND DISTRESSING. IT WAS VERY DIFFICULT FOR ME TO SEE AND SAFELY REMOVE THE BROKEN PIECE. I SPENT A SIGNIFICANT AMOUNT OF TIME AND EFFORT TRYING TO EXTRACT THE MATERIAL FROM MY GUM LINE, WHICH CAUSED A GREAT DEAL OF ANXIETY AND PHYSICAL DISCOMFORT. WHILE I DID NOT END UP NEEDING A DENTIST TO REMOVE IT, I AM VERY CONCERNED THAT THE PRODUCT FAILED SO EASILY DURING NORMAL USE. I NO LONGER HAVE THE ORIGINAL PACKAGING OR THE LOT NUMBER, BUT I HAVE A PHOTO OF THE BROKEN PICK AND THE TIP THAT SNAPPED OFF. I WOULD LIKE TO KNOW HOW YOU INTEND TO RECTIFY THIS SITUATION AND WHAT YOU ARE DOING TO ENSURE THE QUALITY AND SAFETY OF THESE PICKS.