inforMED
MalfunctionEFW

REACH

Received Feb 24, 2021 · Event occurred Jan 26, 2021

Report 3016852456-2021-00001 · MDR key 11376764

Device

Generic name

Manual Toothbrush

Model number

ADR 7 CT FIRM

Lot number

3579T

Product problems

  • Device Slipped

Patient

Not reported

  • Insufficient Information
  • Insufficient Information

Narrative

Additional Manufacturer Narrative

WE WERE NOT ABLE TO INVESTIGATE FURTHER AS PRODUCT WAS NOT RETURNED BY CONSUMER. MANUFACTURER HAS TESTED THE RETAINED SAMPLES FOR TUFT RETENTION AND THE SAMPLES WERE FOUND WITHIN SPECIFICATION.

Description of Event or Problem

BRISTLES COMING OFF WHILE USING THE TOOTHBRUSH.