Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRORALCARERFLSIOSRS; TOOTHBRUSH, POWERED - JEQ
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRORALCARERFLSIOSRS; TOOTHBRUSH, POWERED - JEQ Back to Search Results
Lot Number A315702
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Product return was not received.Product return was requested.Full evaluation will occur upon receipt of product return.
 
Event Description
Brush head came off.Not stuck on at the bottom - oral-b [device breakage] started to make a really loud noise - oral-b [device physical property issue].Case narrative: consumer via phone stated that the oral-b toothbrush started to make a really loud noise and the oral-b toothbrush head came off/would not stick on at the bottom of the oral-b toothbrush.No injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORALBPWRORALCARERFLSIOSRS
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)
UNSPECIFIED MANUFACTURER
unspecified address
unspecified city
Manufacturer Contact
mgr. affairs, oral care-see co
mason business center 8700 ma
son-montgomery rd
mason 45040
MDR Report Key19213015
MDR Text Key341524270
Report Number3000302531-2024-00185
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)Y
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 04/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot NumberA315702
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
ORALBRCHGTOOTHBRUSHHANDLE3758IOSRS9M9 (ORAL-B/RECH
-
-