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

Device Problems Break (1069); Detachment Of Device Component (1104); Loose or Intermittent Connection (1371); Sticking (1597)

Patient Problems Physical Entrapment (2327); 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

Catching lip [lip injury].Brushhead keeps (catching) lip [injury associated with device].Brushhead comes loose and moves [device connection issue].Brushheads broke / brushhead came off in mouth [device breakage].Case description: a (b)(6) female consumer reported that she had used 4 oral-b brushheads, version unknown with an oral-b rechargeable toothbrush, version unknown and described that they all broke within 2 weeks.She stated that the brush which brushes the teeth always came completely loose and moved all over the place, so it kept catching her lip.She asserted that the last brushhead she had suddenly came off in her mouth.The case outcome was unknown.No further information was provided.

• Brand Name: ORAL-B BRUSHHEADS, VERSION UNKNOWN
• Type of Device: TOOTHBRUSH HEAD REFILL
• 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: 5104444
• MDR Text Key: 26950810
• Report Number: 3000302531-2015-00300
• 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,foreign
• Reporter Occupation: Other
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2015
• 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
• Patient Age: 20 YR