MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B PROFESSIONAL CARE RECHARGEABLE TOOTHBRUSH; JEQ,TOOTHBRUSH, POWERED

Device Problems Crack (1135); Loose or Intermittent Connection (1371)

Patient Problems Complaint, Ill-Defined (2331); Tooth Fracture (2428)

Event Date 03/01/2015

Event Type  malfunction  

Event Description

Cracked a molar #2 into two loose pieces/broke just above the gumline/tooth broke into pieces in mouth [tooth fracture], broke 3 fillings, pulled out filling, disintegrated filling -teeth-tooth i loosened a front filling on tooth #24 [device damage], aggravated another tooth [tooth disorder], brush hurt [toothache], toothbrush was much stronger than what is used to i vibration was the cause of the (damage) to my tooth [device physical property issue].Case description: an adult female consumer of unspecified age reported that she used the oral-b professional care 1000 rechargeable toothbrush in (b)(6) 2015 for the first time two weeks ago and it broke 3 of her fillings.She explained that the toothbrush was much stronger than what she was used to and immediately after using it, the toothbrush had pulled out a filling in her front tooth, disintegrated a filling in her back tooth, and aggravated another tooth.She reported that she had been to the dentist where they replaced a filling on her front tooth, and she still had to go back to get a crown on her back tooth.Product use had been discontinued, as she asserted that she would not be using the toothbrush again.Other relevant history: medical history- tooth repair (fillings).The case outcome was not recovered/not resolved.No further information was provided.(b)(6) 2015 received consumer relation's follow-up phone call with consumer: the consumer described that the toothbrush was like a jack hammer in her mouth.She asserted that she hardly used any pressure at all.The case outcome remained not recovered/not resolved.No further information was provided.On (b)(6) 2015 received consumer's follow-up letter and purchase receipt: the consumer reported that she was not happy with the oral-b precision 1000 toothbrush as she found it like a jackhammer in her mouth.She described that it loosened a front filling on tooth #24 and cracked molar #2 into two loose pieces.She reported that she now needs a crown on this #2 tooth.The case outcome remained not recovered/not resolved.No further information was provided.On (b)(6) 2015 received e-mail from promotions team: the consumer returned the product for refund.Per company promotions department process, the product was destroyed and no longer available for investigation.On (b)(6) 2015 received follow-up letter from consumer dated (b)(6) 2015: the consumer stated that she visited two dentists and both of them told her that tooth #2 would need a crown since it broke just above the gumline.She asserted that she felt the vibrations of the toothbrush were the cause of the damage to her tooth, as they were way too forceful against the teeth.The case outcome remained not recovered/not resolved.No further information was provided.On (b)(6) 2015 received dental bills, as follows: the consumer visited the dentist on (b)(6) 2015 and underwent a limited oral evaluation where the decided treatment for tooth 24 was resin-three surfaces, anterior (mesial-facial-lingual).Additionally, she visited the dentist again on (b)(6) 2015 underwent a periodic oral evaluation and intraoral-complete series as requested by the dentist in order to fix tooth #2, where it was decided that she would require a composite restoration porcelain: facial-buccal-mesial surfaces on tooth 2 along with a core buildup, including any pins.On (b)(6) 2015 she visited the dentist for the completion of the resin-three surfaces repair on tooth 24.She had an appointment again on (b)(6) 2015 where she underwent the composite restoration porcelain: facial-buccal-mesial surfaces of tooth 2, along with the core buildup, including any pins.It was reported that she had an upcoming appointment on (b)(6) 2015 for another composite restoration porcelain: facial-buccal-mesial surfaces of tooth 2.The case outcome remained not recovered/not resolved.No further information was provided.On 15-apr-2015 received questionnaire dated (b)(6) 2015: the consumer, a (b)(6) female, used the oral-b professional care 1000 toothbrush from (b)(6) 2015 2 times a day, for 2 minutes each time.She had previously used an older oral-b toothbrush for 15 years and described that it was much gentler and didn't vibrate on her teeth, but stated that with this new replacement toothbrush, she only used it off and on for these 5 days as it hurt and felt like a jackhammer against her teeth.She stated that it vibrated terribly and as such, she had to slightly hold the brush head away from her teeth for the 2 minutes as she was afraid of aggravating her gums with all that force.She reported that her tooth broke into pieces in her mouth, and that she called and visited her dentist where she was advised that she would need a crown as her #2 tooth broke into pieces just above the gumline.She reported that she followed this treatment and that her broken tooth has been recovered.Other relevant history: medical history- rheumatoid arthritis, bi-polar.Allergies- none.Concomitant medications were plaquinel taken once at night to treat rheumatoid arthritis and depakote taken twice daily to treat bi-polar.The case outcome was improved.No further information was provided.

Manufacturer Narrative

The investigation into this alleged product quality complaint is limited due to the fact we do not have a product or a production code to do internal analysis.However, a review of other returns from same product type and a check of the quarterly trend reports since october 2013 indicated no signals related to the complaint on the oral-b rechargeable toothbrushes.We will continue to monitor trends as per normal procedures.

• Brand Name: ORAL-B PROFESSIONAL CARE RECHARGEABLE TOOTHBRUSH
• Type of Device: JEQ,TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; marktheidnfeld ; GM
• Manufacturer (Section G): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidnfeld ; GM
• Manufacturer Contact: mgr, ; mason business ctr; 8700 mason-montgomery rd; mason, OH 45040
• MDR Report Key: 4758435
• MDR Text Key: 5888414
• Report Number: 3000302531-2015-00164
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2015
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 64