MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS; TOOTHBRUSH HEAD REFILL

Model Number EB17

Device Problems Crack (1135); Loose or Intermittent Connection (1371); Material Separation (1562); Device Slipped (1584)

Patient Problem Injury (2348)

Event Type  malfunction  

Event Description

Cheek gets caught [mouth injury].Too much movement between the brush and the holder part, gap [device physical property issue].Doubts brushheads are original [ suspected counterfeit prod].Back of brush cracks, pin comes loose in mouth [device breakage].Case description: a (b)(6) female consumer reported that she used oral-b precision clean brushheads beginning (b)(6) 2014, and there is a gap and too much movement between the brush head and the oral-b rechargeable toothbrush, version unk which causes the cheek to get caught in the brush during brushing.The back of the brush cracks and the pin that holds everything together comes loose and flies off in her mouth.She stated that a new brush had to be used every week.But normally a single brush head lasts 3 months.The consumer suspects the oral-b brush heads are counterfeit.The case outcome was unk.No further info was provided.

Manufacturer Narrative

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

• Brand Name: ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS
• Type of Device: TOOTHBRUSH HEAD REFILL
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; marktheidnfeld ; GM
• Manufacturer (Section G): ORAL-B IRELAND; green rd; newbridge, co kildare ; EI
• Manufacturer Contact: mfr ; 8700 mason-montgomery rd; mason business ctr; mason, OH 45040
• MDR Report Key: 4730754
• MDR Text Key: 5750242
• Report Number: 3000302531-2015-00148
• 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: Foreign,Consumer
• Type of Report: Initial
• Report Date: 03/14/2015

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
• Device Model Number: EB17
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2015
• Initial Date FDA Received: 04/13/2015
• 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: 49 YR