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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS10000N; TOOTHBRUSH, POWERED

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS10000N; TOOTHBRUSH, POWERED Back to Search Results
Model Number 3765
Device Problems Break (1069); Device Slipped (1584); Separation Problem (4043)
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
Female consumer via e-mail stated that a piece broke off of the metal pin to which she attached the brush head to her oral-b genius 10000n electric toothbrush.The brush heads could still be attached, but they did not stay attached securely and kept slipping off during brushing.No injury was reported.
 
Manufacturer Narrative
31-jan-2022 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by a breakage of the tip of the driving shaft due to improper consumer handling, storing and cleaning of the product.
 
Event Description
Female consumer via e-mail stated that a piece broke off of the metal pin to which she attached the brush head to her oral-b genius 10000n electric toothbrush.The brush heads could still be attached, but they did not stay attached securely and kept slipping off during brushing.No injury was reported.03-nov-2021 case update: product lot: bc908071535.No injury was reported.
 
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Brand Name
ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS10000N
Type of Device
TOOTHBRUSH, POWERED
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
regulatory oral care
8700 mason-montgomery rd.
mason, OH 45040
MDR Report Key12657553
MDR Text Key279784833
Report Number3000302531-2021-00335
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeGM
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 09/23/2021
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 Number3765
Device Lot NumberBC908071535
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/23/2021
Initial Date FDA Received10/19/2021
Supplement Dates Manufacturer Received01/31/2022
Supplement Dates FDA Received02/22/2022
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
ORAL-B BRUSHHEADS, VERSION UNKNOWN.; ORAL-B BRUSHHEADS, VERSION UNKNOWN.
Patient SexFemale
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