MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B FLOSS ACTION BRUSH HEAD; TOOTHBRUSH, POWERED

Lot Number NOT AVAILABLE

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Abrasion (1689); Irritation (1941); Injury (2348)

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

Scraped gums [gingival injury].Scraping feeling inside of mouth [mouth injury].Irritated gums [gingival discomfort].Pin sticking out of the brush head/silver pin coming out of the top of the brush head - oral-b brush head [device breakage].Consumer contacted via phone and stated that the pin came out of the top of the brush head.No serious injuries were reported.

Event Description

Scraped gums [gingival injury], scraping feeling inside of mouth [mouth injury], irritated gums [gingival discomfort], pin sticking out of the brush head/silver pin coming out of the top of the brush head - oral-b brush head [device breakage].Case description: consumer contacted via phone and stated that the pin came out of the top of the brush head.No serious injuries were reported.

Manufacturer Narrative

06-jul-2020 product investigation results: product return was received and investigated.Product investigation results showed that complaint was caused by a breakage of the refill due to improper consumer handling.

• Brand Name: ORAL-B FLOSS ACTION BRUSH HEAD
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 9896839
• MDR Text Key: 191198460
• Report Number: 3000302531-2020-00057
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN