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

Lot Number NOT AVAILABLE

Device Problems Detachment Of Device Component (1104); Crack (1135)

Patient Problem Laceration(s) (1946)

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 returned product.

Event Description

Cutting cheek - mouth [mouth injury] plastic keeps splitting and cracking at the bottom of the toothbrush head, round part where bristles located detaches and keeps cutting cheek - oral-b precision clean brushhead [injury associated with device] plastic keeps splitting and cracking at the bottom of the toothbrush head, round part where bristles located detaches - oral-b precision clean brushhead [device breakage] case description: a consumer of unspecified age and gender reported spontaneously via e-mail on 09-nov-2017 that he/she had purchased the oral-b precision clean brushheads and had needed to replace them twice in less than one month.The consumer described that the plastic kept splitting and cracking at the bottom of the toothbrush head.Also, the round part where the bristles were located detached while the toothbrush was going and kept cutting his/her cheek.The consumer asserted that he/she had used oral-b electric toothbrushes and heads for years and had never encountered this issue before.The consumer recounted that he/she had gone through 2 brush heads in less than 1 month, and typically each head lasted him/her 3 months and then he/she replaced them.The case outcome was unknown.Treatment details: unknown.Concomitant product(s): oral-b rechargeable toothbrush, version unknown.No further information was provided.

Manufacturer Narrative

02-jan-2018 product investigation results: reporter returned an unspecified number of toothbrush heads on 12-dec-2017.Toothbrush heads confirmed to be counterfeit.

Event Description

Cutting cheek - mouth [mouth injury].Plastic keeps splitting and cracking at the bottom of the toothbrush head, round part where bristles located detaches and keeps cutting cheek - oral-b precision clean brushhead [injury associated with device].Plastic keeps splitting and cracking at the bottom of the toothbrush head, round part where bristles located detaches - oral-b precision clean brushhead [device breakage] product counterfeit [product counterfeit].Case description: a consumer of unspecified age and gender reported spontaneously via e-mail on 09-nov-2017 that he/she had purchased the oral-b precision clean brushheads and had needed to replace them twice in less than one month.The consumer described that the plastic kept splitting and cracking at the bottom of the toothbrush head.Also, the round part where the bristles were located detached while the toothbrush was going and kept cutting his/her cheek.The consumer asserted that he/she had used oral-b electric toothbrushes and heads for years and had never encountered this issue before.The consumer recounted that he/she had gone through 2 brush heads in less than 1 month, and typically each head lasted him/her 3 months and then he/she replaced them.The case outcome was unknown.Treatment details: unknown.Concomitant product(s): oral-b rechargeable toothbrush, version unknown.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
• MDR Report Key: 7099140
• MDR Text Key: 95065266
• Report Number: 3000302531-2017-00426
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/29/2018
• 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