MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSFLOSSACTNEB25BRUSHSET4CT; TOOTHBRUSH, POWERED

Model Number EB25

Device Problems Break (1069); Separation Problem (4043)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

The reporter informed the company that the product had been discarded.

Event Description

Catching skin inside mouth, cheek [mouth injury]; bleed - cheek [mouth haemorrhage]; brush head separated in two, broke [device breakage]; the space between the round head and the arm it was attached to had got wider [device physical property issue]; consumer e-mailed and stated that the whole brush head separated in two, it broke.No serious injury was reported.

• Brand Name: ORALBPWRPWRORALCARERFLSFLOSSACTNEB25BRUSHSET4CT
• Type of Device: TOOTHBRUSH, POWERED
• 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: regulatory oral care ; 8700 mason-montgomery rd; mason, OH 45040
• MDR Report Key: 8757437
• MDR Text Key: 151124217
• Report Number: 3000302531-2019-00113
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2019

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 Model Number: EB25
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/03/2019
• 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 Number: 1