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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 Structural Problem (2506); Detachment of Device or Device Component (2907)
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 no longer holds the brush properly, it falls off the brush - oral-b [device breakage].The pin on the brush, it is shorter than normal - oral-b [device physical property issue].Female consumer via phone stated that the oral-b toothbrush no longer held the oral-b toothbrush head properly and it fell off of the brush.The pin on the oral-b toothbrush was shorter than normal.No injury was reported.
 
Event Description
Toothbrush no longer holds the brush properly, it falls off the brush - oral-b [device breakage].The pin on the brush, it is shorter than normal - oral-b [device physical property issue].Case narrative: female consumer via phone stated that the oral-b toothbrush no longer held the oral-b toothbrush head properly and it fell off of the brush.The pin on the oral-b toothbrush was shorter than normal.No injury was reported.On 05-sep-32022: case update: the concomitant product was oral-b power oral care refills crossaction eb50rb.No injury was reported.On 22-feb-2023: case update: the concomitant product lot was h1290.No injury was reported.
 
Manufacturer Narrative
On 20-feb-2023 product investigation results: complained product received user handling was identified as root cause for the complaint.
 
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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 ma
son-montgomery rd
mason 45040
MDR Report Key15140500
MDR Text Key304795455
Report Number3000302531-2022-00292
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 03/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number4729
Device Lot Number1BD94430822
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
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 (NOT APPLICABLE; ORALBPWRPWRORALCARERFLSCROSSACTNEB50RB (ORAL-B POW
Patient SexFemale
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