MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLEVITALITY3709; TOOTHBRUSH, POWERED

Lot Number 3709 N2820 545

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212); Device Emits Odor (1425); Sticking (1597)

Patient Problems Dyspnea (1816); Itching Sensation (1943); Respiratory Distress (2045); Burning Sensation (2146); Choking (2464)

Event Type  malfunction  

Manufacturer Narrative

Return of product has been requested.Product 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

Gasping for air [dyspnoea].Itching, burning sensation - throat [throat irritation].Brush head popped off/ broke off toothbrush [device breakage].The brush head broke off toothbrush and got stuck in back of throat [foreign body].Hit back of throat [pharyngeal injury].Brush head popped off and hit back of throat and inner cheek [injury associated with device].Choked [choking].Case description: a (b)(6) female consumer reported via phone on (b)(6) 2016 that while using an oral-b power rechargeable toothbrush handle vitality 3709 on (b)(6) 2016, the oral-b brushhead, version unknown popped off and flew into her throat, and she choked.It was the first use of the toothbrush, and she had left the brush head from the package on the handle.Less than a minute into use, the brush head broke off and got stuck in the back of her throat.She stated she was gasping for air because the toothbrush head hit the back of her throat.She immediately had itching and a burning sensation to her throat.She used chloraseptic spray, and the symptoms recovered (b)(6) 2016.The brush head also hit her inner cheek, but no symptoms were reported at this site.The consumer did not seek medical attention.The consumer discontinued use of the product.She later turned the toothbrush back on, and stated it smelled burned.She reported the brush head was very secure on the handle, the charger base and toothbrush had never been dropped, and the product did not appear damaged.She reported she had used the same type of oral-b toothbrush for a long time.She noted the current toothbrush had a pink band only on it, and not a blue band and pink band that she had usually seen on the brush handle.The scratch test was performed, and the logo did not come off.She used crest arctic fresh toothpaste gel with the product.She had used this toothpaste previously with the same type of brush head, and never had an issue.The case outcome was recovered.Relevant history: allergy/intolerance: seasonal allergy.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLEVITALITY3709
• 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: 5794946
• MDR Text Key: 50408270
• Report Number: 3000302531-2016-00316
• 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: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 3709 N2820 545
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR