MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3756; TOOTHBRUSH, POWERED - JEQ

Model Number 3756

Device Problems Break (1069); Crack (1135)

Patient Problem Tooth Fracture (2428)

Event Type  malfunction  

Manufacturer Narrative

Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.

Event Description

Broke tooth/damage/crack one tooth [tooth fracture].Little metal piece where the toothbrush attaches ejected - oral-b [device breakage].Case narrative: a relative spontaneously reported via phone on 20-apr-2022 that their mother in law (female of unspecified age) used oral-b power rechargeable toothbrush handle with oral-b power power oral care refills (beginning on an unspecified date) and the little metal piece where the toothbrush attached ejected, which broke her tooth (on an unspecified date).Additional product usage details were not specified.The event outcome was unknown.Treatment details: none reported.Relevant history: none reported.Exact device used previously: unknown.Concomitant product(s): none reported.The case outcome was unknown.No further information was provided.21-apr-2022 follow up via phone: the 75 year old female patient¿s daughter in law reported that the device that caused the damaged/cracked tooth was oral-b power rechargeable toothbrush handle 3756 with oral-b power power oral care refills (beginning use on an unspecified date).The patient used the device two times for 2-3 minutes and stopped use of the device on an unspecified date.The event outcome was not recovered/not resolved.Treatment details: she saw a dentist in their office.She used an unspecified treatment.Relevant history: no allergies.The case outcome was not recovered/not resolved.No further information was provided.04-may-2022 case update: the suspect product was oral-b power rechargeable toothbrush handle 3756 and the concomitant product was oral-b power power oral care refills.The event outcome and case outcome remained not recovered/not resolved.No further information was provided.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3756
• Type of Device: TOOTHBRUSH, POWERED - JEQ
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld D-978 28; GM D-97828
• Manufacturer (Section G): UNSPECIFIED MANUFACTURER; unspecified address; unspecified city
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700; mason-montgomery rd; mason 45040
• MDR Report Key: 14351600
• MDR Text Key: 300037363
• Report Number: 3000302531-2022-00185
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3756
• Device Lot Number: 60110
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ORAL-B BRUSHHEADS, VERSION UNKNOWN (ORAL-B POWER/P
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Female