MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3756; TOOTHBRUSH, POWERED - JEQ

Model Number 3756

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330); Unspecified Tissue Injury (4559)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(nicking) gums causing bleeding [gingival bleeding] (nicked) side of mouth.Cause bleeding [mouth haemorrhage] nicking gums [gingival injury] nicked side of mouth [mouth injury] (nicked) gums.Discomfort [gingival discomfort] (nicked) side of mouth.Discomfort [oral discomfort] brush heads don't stay inside.Will pop out - oral-b [device breakage] case narrative: a 69 year old male consumer via phone stated that the replaced oral-b toothbrush heads did not stay inside and popped out while he was brushing.The metal part nicked his gums and the side of his mouth, causing discomfort and bleeding in both locations.No serious injury was reported.

Event Description

(nicking) gums causing bleeding [gingival bleeding] (nicked) side of mouth.Cause bleeding [mouth haemorrhage] nicking gums [gingival injury] nicked side of mouth [mouth injury] (nicked) gums.Discomfort [gingival discomfort] (nicked) side of mouth.Discomfort [oral discomfort] brush heads don't stay inside.Will pop out - oral-b [device breakage] case narrative: a 69 year old male consumer via phone stated that the replaced oral-b toothbrush heads did not stay inside and popped out while he was brushing.The metal part nicked his gums and the side of his mouth, causing discomfort and bleeding in both locations.No serious injury was reported.09-may-2023 case update from information initially received on 14-feb-2023: the suspect product lot was 1cd92110343.No serious injury was reported.23-may-2023 case update from information initially received on 18-apr-2023: the concomitant product lot was i1207 91394682.No serious injury was reported.

Manufacturer Narrative

(b)(6) 2023 product investigation results: product return was received and evaluated.No failure could be identified, the product is according to specifications.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3756
• 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: 16435013
• MDR Text Key: 310367484
• Report Number: 3000302531-2023-00088
• 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,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3756
• Device Lot Number: 1CD92110343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• 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: ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20EB50BRUSH; ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20EB50BRUSH
• Patient Age: 69 YR
• Patient Sex: Male