inforMED
MalfunctionJEQ

ORALBPWRBATTTOOTHBRUSHHANDLECROSSACTNPWR4732

Received Dec 10, 2018

Report 3000302531-2018-00301 · MDR key 8146141

Device

Generic name

Toothbrush, Powered

Model number

4732

Lot number

937

Product problems

  • Detachment of Device or Device Component

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

REPORTER RETURNED PRODUCT ON (B)(6) 2018. THE PRODUCT WAS IDENTIFIED AS AN ORAL-B POWER BATTERY TOOTHBRUSH HANDLE CROSS ACTION POWER 4732 ON (B)(6) 2019. PRODUCT INVESTIGATION RESULTS SHOWED THAT THE COMPLAINT WAS CAUSED BY WEAR OF PLASTIC PARTS DUE TO USAGE OF ABRASIVE TOOTHPASTE IN COMBINATION WITH INSUFFICIENT CLEANING.

Description of Event or Problem

CONSUMER CALLED STATING THAT THE HEAD OF HIS/HER TOOTHBRUSH WAS COMING OFF THE HANDLE WHEN HE/SHE BRUSHED. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

PRODUCT RETURN WAS NOT RECEIVED. A VALID PRODUCTION CODE HASN'T BEEN PROVIDED BY THE REPORTER, THEREFORE NO FURTHER PRODUCT INVESTIGATION POSSIBLE. PRODUCT RETURN WAS REQUESTED. FULL EVALUATION WILL OCCUR UPON RECEIPT OF RETURNED PRODUCT.

Description of Event or Problem

CONSUMER CALLED STATING THAT THE HEAD OF HIS/HER TOOTHBRUSH WAS COMING OFF THE HANDLE WHEN HE/SHE BRUSHED. NO INJURY WAS REPORTED.