MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B BRUSHHEADS, VERSION UNKNOWN; TOOTHBRUSH, POWERED

Lot Number NOT AVAILABLE

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135)

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

Poked in mouth/cheek [mouth injury].Hurt mouth [oral pain].Brush head came off in mouth and poked in cheek/mouth, think it was little metal piece that poked - oral b toothbrush [injury associated with device].Brush head came off, little metal piece, crack in that piece - oral b toothbrush [device breakage].Case description: a female consumer, age (b)(6), reported via phone on (b)(6) 2016 that while using a oral-b rechargeable toothbrush, version unknown that morning, the oral-b brushhead, version unknown came off in her mouth and poked her in her cheek/mouth.She stated she had the oral-b toothbrush for 10 years, and it actually hurt her mouth.She thought it was the little metal piece that poked her; it looked like there was a crack in that piece.She stated she placed a new refill on the toothbrush and it seemed to hold together, but she had not used it yet.The consumer reported she had used the product twice a day.The case outcome was unknown.

• Brand Name: ORAL-B BRUSHHEADS, VERSION UNKNOWN
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): 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: 6166983
• MDR Text Key: 62673084
• Report Number: 3000302531-2016-00485
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2016

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 Number: NOT AVAILABLE
• Other Device ID Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/12/2016
• 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
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN
• Patient Age: 67 YR