• 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 ORAL-B PRECISION CLEAN BRUSHHEADS; 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 ORAL-B PRECISION CLEAN BRUSHHEADS; TOOTHBRUSH, POWERED - JEQ Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Discomfort (2330)
Event Type  malfunction  
Event Description
Irritated gums [gingival discomfort].1 of your medal rods came off in mouth - oral-b [device breakage].Case narrative: elderly female consumer via phone stated that she felt this weird thing in her mouth and upon investigation, she found that one of the medal rods on the oral-b came off in her mouth.No serious injury was reported.
 
Manufacturer Narrative
Product return was requested or its in transport.Evaluation will occur upon receipt of product return.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORAL-B PRECISION CLEAN BRUSHHEADS
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 Key16962224
MDR Text Key315567480
Report Number3000302531-2023-00209
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 05/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/19/2023
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 Unknown
Patient Sequence Number1
Treatment
ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A
Patient SexFemale
-
-