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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3766; TOOTHBRUSH, POWERED - JEQ

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3766; TOOTHBRUSH, POWERED - JEQ Back to Search Results
Model Number 3766
Device Problems Degraded (1153); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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
Toothbrush itself is very smooth and also does not stay in place and lying down properly.- oral-b [device connection issue].Rust forms - oral-b [device physical property issue].Case narrative: male consumer via e-mail stated that the oral-b toothbrush (pin) itself was very smooth and the oral-b toothbrush head refill did not stay in place or lie down properly.He also reported that rust would form.No injury was reported.
 
Manufacturer Narrative
03-mar-2023 product investigation results: complained product received user handling was identified as root cause for the complaint.
 
Event Description
Toothbrush itself is very smooth and also does not stay in place and lying down properly - oral-b [device connection issue] rust forms - oral-b [device physical property issue] case narrative: male consumer via e-mail stated that the oral-b toothbrush (pin) itself was very smooth and the oral-b toothbrush head refill did not stay in place or lie down properly.He also reported that rust would form.No injury was reported.20-jan-2023 case update: the suspect product was oral-b power rechargeable toothbrush handle 3766.The suspect product lot was 2cb90621911.No injury was reported.03-mar-2023 case update: the concomitant product lot (oral-b power power oral care refills crossaction eb50black) was n1083.No injury was reported.
 
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Brand Name
ORALBPWRRCHGTOOTHBRUSHHANDLE3766
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)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld D-978 28
GM   D-97828
Manufacturer Contact
mgr. affairs, oral care-see co
mason business center 8700 ma
son-montgomery rd
mason 45040
MDR Report Key15930882
MDR Text Key307834559
Report Number3000302531-2022-00438
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)Y
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3766
Device Lot Number2CB90621911
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/07/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/15/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
ORALBPWRPWRORALCARERFLSCROSSACTNEB50BLACK (ORAL-B; ORALBPWRPWRORALCARERFLSCROSSACTNEB50BLACK (ORAL-B; ORALBPWRPWRORALCARERFLSSENSIULTRATHINEB60 (ORAL-B; ORALBPWRPWRORALCARERFLSSENSIULTRATHINEB60 (ORAL-B; TOOTHPASTE (),; TOOTHPASTE (),
Patient SexMale
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