inforMED
MalfunctionJEQ

ORALBPWRBATTTOOTHBRUSHHANDLECROSSACTNPWR4732

Received Apr 30, 2019

Report 3000302531-2019-00075 · MDR key 8566226

Device

Generic name

Toothbrush, Powered

Model number

4732

Lot number

NOT AVAILABLE

Product problems

  • Break
  • Detachment of Device or Device Component

Patient

Not reported

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Additional Manufacturer Narrative

PRODUCT RETURN WAS NOT RECEIVED. PRODUCT RETURN WAS REQUESTED. FULL EVALUATION WILL OCCUR UPON RECEIPT OF RETURNED PRODUCT.

Description of Event or Problem

DISCONNECTED BRUSH HEAD LODGING TOWARD BACK OF THROAT [FOREIGN BODY IN RESPIRATORY TRACT]. HEADS DISCONNECTING FROM THE TOOTHBRUSH [DEVICE BREAKAGE]. THE NIPPLE AT THE END OF THE PORTION THAT SLIDES INTO THE TOOTHBRUSH AND IS SUPPOSED TO LOCK THE HEAD ONTO THE TOOTHBRUSH IN INSUFFICIENT TO DO SO / NIPPLE WILL NOT KEEP THE HEAD LOCKED ONTO THE TOOTHBRUSH [DEVICE CONNECTION ISSUE]. CONSUMER E-MAILED AND STATED THAT HE/SHE HAD A PROBLEM OF THE TOOTHBRUSH HEADS DISCONNECTING FROM THE TOOTHBRUSH. NO SERIOUS INJURY WAS REPORTED.

Description of Event or Problem

DISCONNECTED BRUSH HEAD LODGING TOWARD BACK OF THROAT [FOREIGN BODY IN RESPIRATORY TRACT]. HEADS DISCONNECTING FROM THE TOOTHBRUSH [DEVICE BREAKAGE] THE NIPPLE AT THE END OF THE PORTION THAT SLIDES INTO THE TOOTHBRUSH AND IS SUPPOSED TO LOCK THE HEAD ONTO THE TOOTHBRUSH IN INSUFFICIENT TO DO SO / NIPPLE WILL NOT KEEP THE HEAD LOCKED ONTO THE TOOTHBRUSH [DEVICE CONNECTION ISSUE] CONSUMER E-MAILED AND STATED THAT HE/SHE HAD A PROBLEM OF THE TOOTHBRUSH HEADS DISCONNECTING FROM THE TOOTHBRUSH. NO SERIOUS INJURY WAS REPORTED.

Additional Manufacturer Narrative

PRODUCT RETURN WAS RECEIVED ON 28-MAY-2019 AND IDENTIFIED AS AN ORAL-B POWER BATTERY TOOTHBRUSH HANDLE CROSS ACTION POWER 4732 ON 05-JUN-2019. PRODUCT INVESTIGATION IS IN PROGRESS.