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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3764PRO6500MODELD36.545.5HX; TOOTHBRUSH, POWERED - JEQ

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3764PRO6500MODELD36.545.5HX; TOOTHBRUSH, POWERED - JEQ Back to Search Results
Model Number D36.545.5HX
Device Problems Break (1069); Degraded (1153)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Brushheads no longer staying securely attached and keep falling off - oral-b [device breakage].Severe abrasion on the metal pin - oral-b [device physical property issue].Case narrative: female consumer via e-mail stated that their oral-b electric triumph professional care pro 6500 toothbrush had severe abrasion on the metal pin.The original oral-b toothbrush heads no longer stayed securely attached and kept falling off mid-brushing.No injury was reported.
 
Manufacturer Narrative
Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.
 
Manufacturer Narrative
01-sep-2022 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by wear of the driving shaft and plastic parts due to usage of abrasive toothpaste in combination with insufficient cleaning with use over many years.
 
Event Description
Brushheads no longer staying securely attached and keep falling off - oral-b [device breakage] severe abrasion on the metal pin - oral-b [device physical property issue] case narrative: female consumer via e-mail stated that their oral-b electric triumph professional care pro 6500 toothbrush had severe abrasion on the metal pin.The original oral-b toothbrush heads no longer stayed securely attached and kept falling off mid-brushing.No injury was reported.
 
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Brand Name
ORALBPWRRCHGTOOTHBRUSHHANDLE3764PRO6500MODELD36.545.5HX
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
mason-montgomery rd
mason 45040
MDR Report Key15041543
MDR Text Key303809640
Report Number3000302531-2022-00271
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)Y
Reporter Country CodeAU
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 09/22/2022
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 NumberD36.545.5HX
Device Lot NumberR 71920312
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 Received07/18/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/26/2022
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 (NOT APPLICABLE.; ORAL-B BRUSHHEADS, VERSION UNKNOWN (NOT APPLICABLE.
Patient SexFemale
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