MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B TRIUMPH PROFESSIONALCARE DENTA-PRIDE, VERSION UNKNOWN; TOOTHBRUSH, POWERED

Device Problems Break (1069); Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

Return of product has been requested.Product and lot number not provided by the reporter, therefore unable to proceed with product investigation at this time.Full evaluation will occur upon receipt of the returned product.

Event Description

Hit cheek causing a little wound on right cheek [mouth injury].Hit teeth [tooth injury].Stabbed in face [face injury].Plastic collar that surrounds the metal post cracked so the brush head came off in mouth [device breakage].Brush head came off in mouth causing wound on cheek, stabbed in face [injury associated with device].Case description: a (b)(6) year old female consumer reported that she used an oral-b triumph professional care (b)(6), version unknown, and the plastic collar that surrounds the metal post of the toothbrush cracked, causing the oral-b brushhead, version unknown to come off in her mouth and it stabbed her in the face.She reported that the metal post hit her in the teeth and right cheek which caused a little wound on her cheek.She stated she had the oral-b triumph power toothbrush for a long time.The case outcome was recovered.

Manufacturer Narrative

09-feb-2016 product investigation results: the reporter returned one oral-b rechargeable toothbrush handle on 19-jan-2016.Manufactured as intended based on investigation.Root cause for the wear is the usage over a long time.The handle has reached its end of life.

Event Description

Hit cheek causing a little wound on right cheek [mouth injury]; hit teeth [tooth injury]; stabbed in face [face injury]; plastic collar that surrounds the metal post cracked so the brush head came off in mouth [device breakage]; brush head came off in mouth causing wound on cheek, stabbed in face [injury associated with device].Case description: a (b)(6) female consumer reported that she used an oral-b triumph professional care denta-pride, version unknown, and the plastic collar that surrounds the metal post of the toothbrush cracked, causing the oral-b brushhead, version unknown to come off in her mouth and it stabbed her in the face.She reported that the metal post hit her in the teeth and right cheek which caused a little wound on her cheek.She stated she had the oral-b triumph power toothbrush for a long time.The case outcome was recovered.

• Brand Name: ORAL-B TRIUMPH PROFESSIONALCARE DENTA-PRIDE, VERSION UNKNOWN
• 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 road; mason, OH 45040
• MDR Report Key: 5328903
• MDR Text Key: 35030219
• Report Number: 3000302531-2015-00415
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 55 YR