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 ORALBPWRPWRORALCARERFLSSENCLEANEB60; 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 ORALBPWRPWRORALCARERFLSSENCLEANEB60; TOOTHBRUSH, POWERED - JEQ Back to Search Results
Model Number EB60
Device Problems Material Fragmentation (1261); No Apparent Adverse Event (3189)
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
Pieces of metal when spitting after brushing that came from the head - oral-b [device breakage].Case narrative: consumer via phone stated that pieces of metal from the oral-b toothbrush head came out when spitting after brushing.No injury was reported.
 
Event Description
Pieces of metal when spitting after brushing that came from the head - oral-b [device breakage].Case narrative: consumer via phone stated that pieces of metal from the oral-b toothbrush head came out when spitting after brushing.No injury was reported.
 
Manufacturer Narrative
16-mar-2023 product investigation results: product return was received and evaluated.No failure could be identified, the product is according to specifications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORALBPWRPWRORALCARERFLSSENCLEANEB60
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 Key16294356
MDR Text Key308887113
Report Number3000302531-2023-00060
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)Y
Reporter Country CodeSP
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 04/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberEB60
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 RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A
-
-