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

Lot Number NOT AVAILABLE

Device Problems Break (1069); Crack (1135)

Patient Problems Inflammation (1932); Skin Irritation (2076); 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

Feel raw bottom right inside cheek [stomatitis].Feel abrasion bottom right inside cheek [mouth injury].Feel pimple bottom right inside cheek [acne].Bristle part of the refill broke/ separated from the plastic stem, cracked /split along the plastic seam in mouth [device breakage].Case description: report source: spontaneous.A (b)(6) male consumer reported via phone on (b)(6) 2017 that while brushing his teeth with an oral-b power rechargeable toothbrush handle type 4729 on the night of (b)(6) 2017, the bristle part of the oral-b precision clean brushhead broke.He described that while in his mouth, the brush head cracked/ split along the plastic seam and separated from the plastic stem.He reported that in and around where he was brushing at that time, it felt raw in his bottom right cheek, and with his tongue he could feel an abrasion or pimple in his bottom right cheek, all beginning (b)(6) 2017.He reported that his gums seemed okay, and he did not seek medical attention.The brush head had been placed on the toothbrush handle in (b)(6) 2017, used twice a day, and the consumer discontinued use on (b)(6) 2017.The consumer reported he had previously used this exact version of brush heads.The case outcome was not recovered/ not resolved.Relevant history: no allergies.No further information was provided.

Manufacturer Narrative

24-aug-2017 product investigation results: reporter returned toothbrush head on (b)(6) 2017.Toothbrush head confirmed to be counterfeit.

Event Description

Feel raw bottom right inside cheek stomatitis.Feel abrasion bottom right inside cheek mouth injury.Feel pimple bottom right inside cheek acne.Bristle part of the refill broke/ separated from the plastic stem, cracked /split along the plastic seam in mouth device breakage.Product counterfeit.Case description: report source: spontaneous.A (b)(6) year old male consumer reported via phone on (b)(6) 2017 that while brushing his teeth with an oral-b power rechargeable toothbrush handle type 4729 on the night of (b)(6) 2017, the bristle part of the oral-b precision clean brushhead broke.He described that while in his mouth, the brush head cracked/ split along the plastic seam and separated from the plastic stem.He reported that in and around where he was brushing at that time, it felt raw in his bottom right cheek, and with his tongue he could feel an abrasion or pimple in his bottom right cheek, all beginning (b)(6) 2017.He reported that his gums seemed okay, and he did not seek medical attention.The brush head had been placed on the toothbrush handle in (b)(6) 2017, used twice a day, and the consumer discontinued use on (b)(6) 2017.The consumer reported he had previously used this exact version of brush heads.The case outcome was not recovered/ not resolved.Relevant history: no allergies.No further information was provided.

• Brand Name: ORAL-B 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: 6727741
• MDR Text Key: 80699209
• Report Number: 3000302531-2017-00270
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

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 Lot Number: NOT AVAILABLE
• Other Device ID Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 77 YR