MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRORALCARERFLSFLOSSACTNEB25BRUSHSET2CT; TOOTHBRUSH, POWERED - JEQ

Model Number EB25

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Unspecified Tissue Injury (4559)

Event Type  malfunction  

Manufacturer Narrative

Product return was requested or its in transport.Evaluation will occur upon receipt of product return.

Event Description

Bleeding from corner of mouth where upper lip joins [mouth haemorrhage] stabbed inside mouth.Cut mouth [mouth injury] mouth hurt [oral pain] shaft part cracked.Tube under the round brush of the replacement brush was chipped - oral-b [device breakage] case narrative: 47 year old female consumer via phone stated that when she plugged the oral-b toothbrush head refill (eb25rx-hb) into the main oral-b toothbrush unit, the shaft part cracked and it stabbed/cut her inside the mouth, causing her to bleed from the corner of her mouth where the upper lip joins.Her mouth hurt and she felt like she was being pricked by a thorn.The tube under the round oral-b toothbrush of the replacement brush was chipped.No serious injury was reported.05-feb-2024 case update: the concomitant product lot was 032.No serious injury was reported.

Manufacturer Narrative

29-feb-2024 product investigation results: complained product received - user handling was identified as root cause for the complaint.

Event Description

Bleeding from corner of mouth where upper lip joins [mouth haemorrhage] stabbed inside mouth.Cut mouth [mouth injury] mouth hurt [oral pain] shaft part cracked.Tube under the round brush of the replacement brush was chipped - oral-b [device breakage] case narrative: 47 year old female consumer via phone stated that when she plugged the oral-b toothbrush head refill (eb25rx-hb) into the main oral-b toothbrush unit, the shaft part cracked and it stabbed/cut her inside the mouth, causing her to bleed from the corner of her mouth where the upper lip joins.Her mouth hurt and she felt like she was being pricked by a thorn.The tube under the round oral-b toothbrush of the replacement brush was chipped.No serious injury was reported.05-feb-2024 case update: the concomitant product lot was 032.No serious injury was reported.04-mar-2024 amendment from information initially received on 05-feb-2024: the concomitant product lot was u3246.No serious injury was reported.05-mar-2024 case update from product investigation results completed on 29-feb-2024: the suspect product was confirmed to be oral-b power oral care refills floss action eb25 brush set 2ct.The concomitant product was confirmed to be oral-b rechargeable toothbrush handle.No serious injury was reported.

• Brand Name: ORALBPWRORALCARERFLSFLOSSACTNEB25BRUSHSET2CT
• 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 D-978 28; GM D-97828
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700 ma; son-montgomery rd; mason 45040
• MDR Report Key: 18699560
• MDR Text Key: 336414444
• Report Number: 3000302531-2024-00057
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EB25
• Device Lot Number: U3246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2024
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ORALBPWRORALCARERFLSFLOSSACTNEB25BRUSHSET2CT (ORAL; ORALBRCHGTOOTHBRUSHHANDLE (ORAL-B/RECHARGEABLE TOO
• Patient Age: 47 YR
• Patient Sex: Female