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

Lot Number NOT AVAILABLE

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Choking (2464); Foreign Body In Patient (2687)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

Return of product has been requested.Reporter returned toothbrush head on 25-jun-2018.Product investigation is in progress.

Event Description

Choking [choking]; clap her on the back to get it out of her throat- oral-b brush head [foreign body in respiratory tract].Rectangular bit of the brush head came off, clip and metal pin and offset pin came off [device breakage].Distressed [emotional distress].Anxious [anxiety].Case description: a spontaneous report was received via phone on (b)(6) 2018 from a reporter stating that while his wife, age (b)(6), brushed her teeth with an oral-b dual action brushhead on (b)(6) 2018, the rectangular bit of the brush head, clip and metal pin and offset pin, came off and she choked.Their son had to clap her on the back to get it out of her throat.The reporter stated his wife had been using the brush head for 4 to 5 weeks before this happened.She discontinued use of the product on (b)(6) 2018.He reported she has been very distressed and anxious since (b)(6) 2018, and was now using a manual brush.The case outcome was improved.Relevant history: none reported.Concomitant product(s): oral-b rechargeable toothbrush, version unknown.No further information was provided.

Manufacturer Narrative

10-jul-2018 product investigation results: reporter returned toothbrush head on 25-jun-2018.Product return was received and investigated.Investigation results showed that the complaint was caused by wear of plastic parts due to usage of abrasive toothpaste in combination with insufficient cleaning.

Event Description

Choking.Clap her on the back to get it out of her throat- oral-b brush head [foreign body in respiratory tract].Rectangular bit of the brush head came off, clip and metal pin and offset pin came off [device breakage].Distressed [emotional distress].Anxious [anxiety].Case description: a spontaneous report was received via phone on 19-jun-2018 from a reporter stating that while his wife, age 60 years, brushed her teeth with an oral-b dual action brush head on (b)(6) 2018, the rectangular bit of the brush head, clip and metal pin and offset pin, came off and she choked.Their son had to clap her on the back to get it out of her throat.The reporter stated his wife had been using the brush head for 4 to 5 weeks before this happened.She discontinued use of the product on (b)(6) 2018.He reported she has been very distressed and anxious since (b)(6) 2018, and was now using a manual brush.The case outcome was improved.Relevant history: none reported.Concomitant product(s): oral-b rechargeable toothbrush, version unknown.No further information was provided.10-jul-2018 product investigation results: product was returned 25-jun-2018.Conclusion: no manufacturing cause identified based on investigation.

• Brand Name: ORAL-B DUALACTION BRUSHHEADS
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 7663787
• MDR Text Key: 113191792
• Report Number: 3000302531-2018-00173
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• 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: 06/25/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN.; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN.; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR