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

Lot Number NOT AVAILABLE

Device Problems Break (1069); Sticking (1597); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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

Brush head has come off, broke, split [device breakage], no adverse event [no adverse event].Case description: report source: non-event - spontaneous.A male consumer, age unspecified, reported via social media on (b)(6) 2017 he bought 2 packs of 4 oral-b oral-b flexisoft brushheads, and 5 of the brush heads came off/ broke while used with an oral-b rechargeable toothbrush, version unknown.The reporter stated the brush heads split after 2 weeks of use, 5 brush heads had been used, and there were 3 more to go.The consumer reported that nothing happens after scratching the logo; the logo was stuck and it was not a sticker.No symptoms were reported.Relevant history: none reported.No further information was provided.

• Brand Name: ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS
• 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: 6705382
• MDR Text Key: 79963819
• Report Number: 3000302531-2017-00247
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• 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
• Date Manufacturer Received: 06/13/2017
• 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