MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; DIAMOND CLEAN 9000 ACCESSORY CHARGER CUP

Catalog Number HX9914/75

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 08/31/2023

Event Type  Injury  

Manufacturer Narrative

B3: the event date is approximate.G3: the complaint was received from a consumer in south korea.Product was not returned to confirm a malfunction has occurred.H3 other text : product not returned to manufacturer.

Event Description

A consumer reported that a diamondclean 9000 glass charging cup fell onto the back of the consumer's foot.The consumer stated that the injury was caused by them dropping the charging cup while brushing their teeth.Medical intervention was reported.The consumer's foot had to be sutured.

• Brand Name: PHILIPS SONICARE
• Type of Device: DIAMOND CLEAN 9000 ACCESSORY CHARGER CUP
• Manufacturer (Section D): PHILIPS ORAL HEALTHCARE, LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ORAL HEALTHCARE, LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: imke overdevest ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 17874036
• MDR Text Key: 324960366
• Report Number: 3026630-2023-00075
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: HX9914/75
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention