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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE4729; TOOTHBRUSH, POWERED - JEQ

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE4729; TOOTHBRUSH, POWERED - JEQ Back to Search Results
Model Number 4729
Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)
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
Male consumer via e-mail stated that his oral-b brush heads (the originals) kept falling off.No injury was reported.16-aug-2021 follow up via e-mail: male consumer via e-mail stated that he used the brush heads on his oral-b professional care toothbrush model 4729.No injury was reported.
 
Manufacturer Narrative
On 08-jun-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
(oral-b) brush heads (the originals) keep falling off now [device breakage].Case narrative: male consumer via e-mail stated that his oral-b brush heads (the originals) kept falling off.No injury was reported.On 16-aug-2021: follow up via e-mail: male consumer via e-mail stated that he used the brush heads on his oral-b professional care toothbrush model 4729.No injury was reported.
 
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Brand Name
ORALBPWRRCHGTOOTHBRUSHHANDLE4729
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, OH 45040
MDR Report Key12391195
MDR Text Key270505409
Report Number3000302531-2021-00294
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)Y
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 06/28/2022
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 Number4729
Device Lot Number1BD 842 506 34
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/10/2021
Initial Date FDA Received08/31/2021
Supplement Dates Manufacturer Received08/10/2021
Supplement Dates FDA Received06/28/2022
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 Unknown
Patient Sequence Number1
Treatment
ORAL-B BRUSHHEADS, VERSION UNKNOWN; ORAL-B BRUSHHEADS, VERSION UNKNOWN (NOT APPLICABLE)
Patient SexMale
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