MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC. PHILIP SONICARE TOOTHBRUSH HEAD; TOOTHBRUSH, POWERED

Model Number HX6068/82

Device Problem Scratched Material (3020)

Patient Problem Laceration(s) (1946)

Event Date 01/03/2023

Event Type  Injury  

Event Description

I used a new replacement of philip sonicare toothbrush head, which cut my lip, because the brush heads were not molded smoothly.Its sharp edges cut my lips/oral cavity.I was not bleeding, but i was cut.I bought an 8 pc(piece) package from costco, after examining, 6 of the 8 have this issue.I contacted philip's sonicare right after the problem.Philip safety specialist got back to me on (b)(6) 2023.I replied to their investigation on the same day.At the same time, i requested 6 replacements.They committed to address the case in 5 business days, but up to today (b)(6) 2023 i haven't heard anything from them.I followed up 3 times (b)(6) 2023 via email and phone call.No feedback at all.It's an issue not only with the toothbrush head (class i medical device), but also its broken process on customer complaint on medical device.Some pics are uploaded."toothbrush 6" is one that i used the sharp edge to scratch my finger skin.You can see the white scratches/lines.I will return 5 of the 6 problematic toothbrush heads to costco to decrease my loss in this purchase.I will keep one example, for 30 calendar days in my hand in case fda needs to evaluate it.

• Brand Name: PHILIP SONICARE TOOTHBRUSH HEAD
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): PHILIPS ORAL HEALTHCARE, LLC.
• MDR Report Key: 16337019
• MDR Text Key: 309296346
• Report Number: MW5114802
• Device Sequence Number: 2
• 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: 02/05/2023
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: HX6068/82
• Device Catalogue Number: 3860427
• Device Lot Number: 21101221T
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian