MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBMANDENTALFLOSSEXPERTINTERDENTALMICROINTERDENTALBRUSHINTERDENTAL; FLOSS, DENTAL

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Discomfort (2330); Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

Product return was not received.A production code has not been provided by the reporter, therefore a plant investigation cannot be conducted.Further evaluation may occur if the production code or the product is received.

Event Description

Tooth #18 extracted (to give access to foreign object stuck in the root of tooth #17) [tooth loss].Gum perforation [gingival injury].Bleeding (during extraction of tooth #18) - gum [gingival bleeding].Pain - gums [gingival pain].Discomfort - gums [gingival discomfort].Metal shaft of interdental toothbrush stuck inside gums/metallic rod stuck in the root of tooth #17, at a distal to mesial and apical position [foreign body in mouth].Interdental toothbrush broke.Burst open [device breakage].Painful (exams and procedures) - mouth [oral pain].Case description: a spontaneous report was received via email on 30-jul-2021 from a male consumer, age unknown, who used oral-b manual dental floss expert interdental micro interdental brush interdental, beginning on an unspecified date, and the brush broke during use and the metal shaft was stuck inside the gum on (b)(6) 2021.The gum was perforated ((b)(6) 2021).He underwent painful dental exams and procedures, and had to have a tooth extracted (2021) to provide access to the metal shaft stuck in the gum.Bleeding prevented the metal shaft from being removed at the same time as the tooth extraction.The metal shaft was removed from the gum on (b)(6) 2021.The consumer had spent 45 days with the metal shaft stuck in the gum, feeling pain and discomfort.Product usage details were not provided.It was unknown if the consumer had used this version of the product previously.Product use was stopped on (b)(6) 2021.The event outcome of foreign body in mouth was recovered.The event outcomes of tooth loss, gum perforation, bleeding gums, gum pain, gum discomfort, and oral pain were unknown.The case outcome was improved.Relevant history: none reported.Concomitant product(s): none reported.No further information was provided.30-jul-2021 case update: a receipt was received for payment of performed dental treatment.No further information was provided.29-sep-2021 follow-up via phone: the consumer reported that after getting the tooth pulled and taking an anti-inflammatory for a week, he was fine now.He had previously used this version of the product with unknown tolerance.The event outcomes of gum perforation, bleeding gums, gum pain, gum discomfort, and oral pain were recovered (2021).The case outcome remained improved.No further information was provided.30-sep-2021 dental report received: on (b)(6) 2021, the patient called the dental office and reported that during use of the interdental brush, it burst open and part of it got stuck in his gum.He went to the office on (b)(6) 2021 , and a clinical examination was performed by a doctor of dental surgery and periodontal/prosthetics specialist.The foreign object was unable to be visualized, so an x-ray was obtained for further examination.The x-ray results confirmed a foreign object stuck in the root of tooth #17, at a distal to mesial and apical position.The doctor confirmed that the foreign object could not be removed without extracting tooth #18.On (b)(6) 2021, the extraction procedure of tooth #18 was performed, however the bloody area and light bleeding made it impossible to remove the foreign object.14 days later, on (b)(6) 2021, it was possible to access and remove the foreign object.The doctor confirmed that the foreign object was a metallic rod.The case outcome remained improved.No further information was provided.

• Brand Name: ORALBMANDENTALFLOSSEXPERTINTERDENTALMICROINTERDENTALBRUSHINTERDENTAL
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 12722449
• MDR Text Key: 279626737
• Report Number: 3000302531-2021-00346
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 07/30/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/29/2021
• 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 Outcome(s): Other; Required Intervention