MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRORALCARERFLS3DWHITECAP; TOOTHBRUSH, POWERED - JEQ

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Pain (1994); Paresthesia (4421); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

Almost choked [choking sensation].Stomach ache [abdominal pain upper].Throat sore [oropharyngeal pain].Pins and needles all over upper stomach above the belly button, all the way across the abdomen [paraesthesia].The brush head broke of [off] in my mouth / fell in mouth.There's a crack on the side of it too - oral-b [device breakage].Case narrative: a 40 year old female via e-mail stated that while using her oral-b toothbrush, the oral-b brush head broke off in her mouth, had a crack on the side of it, and she almost choked.Also reporting stomach ache, pins and needles all over upper stomach above the belly button, all across the abdomen and throat soreness have occurred.No serious injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

30-apr-2024 case update: other - based on updated assessment provided by gps no reportable event has taken place to the consumer.Hence the actual mdr is obsolete and no longer needed.

Event Description

Almost choked [choking sensation] stomach ache [abdominal pain upper] throat sore [oropharyngeal pain] pins and needles all over upper stomach above the belly button, all the way across the abdomen [paraesthesia] the brush head broke of [off] in my mouth / fell in mouth.There's a crack on the side of it too - oral-b [device breakage] case narrative: a 40 year old female via e-mail stated that while using her oral-b toothbrush, the oral-b brush head broke off in her mouth, had a crack on the side of it, and she almost choked.Also reporting stomach ache, pins and needles all over upper stomach above the belly button, all across the abdomen and throat soreness have occurred.No serious injury was reported.30-apr-2024 case update: based on updated new information (return of physical product to kronberg) no reportable event has taken place to the consumer.Hence the actual mdr was obsolete and no longer needed.No serious injury was reported.

• Brand Name: ORALBPWRORALCARERFLS3DWHITECAP
• Type of Device: TOOTHBRUSH, POWERED - JEQ
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld D-978 28; GM D-97828
• Manufacturer (Section G): UNSPECIFIED MANUFACTURER; unspecified address; unspecified city
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700 ma; son-montgomery rd; mason 45040
• MDR Report Key: 18650354
• MDR Text Key: 334737420
• Report Number: 3000302531-2024-00026
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• 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
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• 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
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A
• Patient Age: 40 YR
• Patient Sex: Female