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

Lot Number NOT AVAILABLE

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Product return was not received.Product return was requested.Full evaluation will occur upon receipt of returned product.

Event Description

Brush head lodged in oesophagus, rotating tip of electric toothbrush felt stuck at level of clavicle [foreign body in gastrointestinal tract].Coughed up brush head [cough].Head came detached from the plastic stick - oral-b [device breakage].Unsure if the head was counterfeit - oral-b [suspected counterfeit product].Case description: consumer reported via e-mail the brush head came detached from the plastic stick and lodged in her esophagus.No serious injury was reported.(b)(6) 2020 follow-up via medical record stated the rotating tip of electric toothbrush was expelled without intervention.No serious injury was reported.

• Brand Name: ORAL-B BRUSHHEADS, VERSION UNKNOWN
• 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 rd; mason, oh
• MDR Report Key: 9911082
• MDR Text Key: 191198495
• Report Number: 3000302531-2020-00059
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2020

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 04/01/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 69