MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE3758IOSRS9; TOOTHBRUSH, POWERED - JEQ

Model Number 3758

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Complained product will not be not available.

Event Description

Teeth damaged.Wedge-shaped defect [tooth injury].Case narrative: a store reported spontaneously via email on 07-oct-2023 that a female consumer (unspecified age) used oral-b rechargeable toothbrush handle 3758 ioseries9 and oral-b power oral care refills io series (beginning on an unspecified date) and experienced damaged teeth, which the dentist diagnosed as a wedge-shaped defect (beginning on an unspecified date).Treatment details: unknown.Product usage details were not provided and it was unknown if product used was stopped.Exact product used previously: unknown.It was reported that she used the soft protective gear.Relevant history: none reported.Concomitant product(s): none reported.The event and case outcomes were unknown.No further information was reported.14-dec-2023 case update from information initially received on 07-oct-2023: the suspect product was confirmed to be oral-b rechargeable toothbrush handle 3758 ioseries9.The concomitant product was confirmed to be oral-b power oral care refills io series.The adverse event outcome remained unknown.The case outcome remained unknown.No further information was reported.

Manufacturer Narrative

12-mar-2024 case update: this case involving a serious adverse event, damage to teeth, was exempt from reporting under "e2013042" and was inadvertently reported to us fda in error.

Event Description

Teeth damaged.Wedge-shaped defect [tooth injury].Case narrative: a store reported spontaneously via email on 07-oct-2023 that a female consumer (unspecified age) used oral-b rechargeable toothbrush handle 3758 ioseries9 and oral-b power oral care refills io series (beginning on an unspecified date) and experienced damaged teeth, which the dentist diagnosed as a wedge-shaped defect (beginning on an unspecified date).Treatment details: unknown.Product usage details were not provided and it was unknown if product used was stopped.Exact product used previously: unknown.It was reported that she used the soft protective gear.Relevant history: none reported.Concomitant product(s): none reported.The event and case outcomes were unknown.No further information was reported.14-dec-2023 case update from information initially received on 07-oct-2023: the suspect product was confirmed to be oral-b rechargeable toothbrush handle 3758 ioseries9.The concomitant product was confirmed to be oral-b power oral care refills io series.The adverse event outcome remained unknown.The case outcome remained unknown.No further information was reported.12-mar-2024 case update from information initially received on 07-oct-2023: this case involving a serious adverse event, damage to teeth, was exempt from reporting under "e2013042" and was inadvertently reported to us fda in error.The adverse event outcome remained unknown.The case outcome remained unknown.No further information was reported.

• Brand Name: ORALBRCHGTOOTHBRUSHHANDLE3758IOSRS9
• 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 ma; son-montgomery rd; mason 45040
• MDR Report Key: 18517384
• MDR Text Key: 332915144
• Report Number: 3000302531-2024-00010
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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: ORALBPWRORALCARERFLSIOSRS (ORAL-B/POWER ORAL CARE; ORALBPWRORALCARERFLSIOSRS (ORAL-B/POWER ORAL CARE
• Patient Outcome(s): Other
• Patient Sex: Female