MAUDE Adverse Event Report: PHILIPS RESPIRONICS PHILIPS SONICARE TOOTHBRUSH HANDLE; TOOTHBRUSH POWERED

Model Number WHITE HX685T, 181011-1A

Device Problems Vibration (1674); Defective Component (2292); Device Dislodged or Dislocated (2923)

Patient Problems Laceration(s) (1946); Pain (1994)

Event Date 11/24/2019

Event Type  Injury  

Event Description

Incident on (b)(6) 2019.A philips sonicare handle model hx685t (181011-1a) is defective.Erratic and violent vibrations from the handle dislodged the secured toothbrush head in my mouth that damaged my crowns and gums.Very painful and caused gum lacerations and tooth (crown) damage.Telephone (b)(6).Foreign call center demanded a receipt.Repeatedly told not to inform or to contact the cpsc in the us and this would be taken care of internally by (b)(6).No offer to pay for dental repairs.No other consumers or children should be damaged in this manner.Thank you for your assistance.See scanned pages.

• Brand Name: PHILIPS SONICARE TOOTHBRUSH HANDLE
• Type of Device: TOOTHBRUSH POWERED
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 9465874
• MDR Text Key: 170895740
• Report Number: MW5091632
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WHITE HX685T, 181011-1A
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR