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 ORALBPWRPWRORALCARERFLSKIDS; TOOTHBRUSH, POWERED
  • 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 ORALBPWRPWRORALCARERFLSKIDS; TOOTHBRUSH, POWERED Back to Search Results
Lot Number NOT AVAILABLE
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); 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 returned product.
 
Event Description
A parent contacted via e-mail and stated that as his/her son was turning his toothbrush on, the brush head fell off; it seemed like there was a crack along where the blue seam was.No injury was reported.
 
Manufacturer Narrative
30-jun-2021 follow up: the reporter informed the company that the product has been discarded.
 
Event Description
A parent contacted via e-mail and stated that as his/her son was turning his toothbrush on, the brush head fell off; it seemed like there was a crack along where the blue seam was.No injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORALBPWRPWRORALCARERFLSKIDS
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM  D-97828
MDR Report Key9428361
MDR Text Key191197858
Report Number3000302531-2019-00222
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 11/09/2019
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 Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/09/2019
Initial Date FDA Received12/06/2019
Supplement Dates Manufacturer Received06/30/2021
Supplement Dates FDA Received07/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN
-
-