MAUDE Adverse Event Report: PROCTER & GAMBLE ORAL-B GLIDE PRO HEALTH; FLOSS, DENTAL

Health Effect - Clinical Codes	Nausea (1970); Malaise (2359)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
I went for a dental cleaning and i noticed during this cleaning that the hygienist brought an oral b glide pro health brand of dental floss.The hygienist used this brand of dental floss on my teeth and gums.Several minutes later as i drove home i experienced nausea and felt unwell which i never experienced before after a mere dental cleaning procedure.I did an online search and found that this product is known to have extremely high amounts of fluorine, with test results of around 250,000 to 380,000 ppm of fluorine which correlates directly with pfas content.The fda has already determined that pfas are toxic at the parts per quadrillion range so that procter & gamble has the audacity not merely to add pfas to their dental floss but to add such extreme and hazardous concentrations of pfas to their products in nothing short of shocking.My doctor has ordered a pfas blood test through (b)(6), and while i understand that this test only shows the most common pfas, i'm hopefully that whatever pfas used by proctor & gamble will be included in the pfas that are tested by this panel.I do believe that the fda should investigate and determine what pfas were used by p&g not merely because they use pfas in their dental floss products but because of the concentrations.I understand that many products have pfas as indicated by their fluorine content in a range of 1-65 ppm, which although it unacceptable, p&g products presents a pfas hazard several of orders of magnitude greater than typical pfas containing product and because of this should be an agency priority.Again the fact that this product is in the quarter million plus ppm range demonstrates it is an emergent hazard to the public, and that even single exposures by individuals such as myself who was exposed in a dental cleaning and does not buy the product, causes a significant increase in pfas body burden and corresponding significant harm.Again that i experienced acute symptoms after this pfas laden floss was used on me, and moreover lab results of fluorine concentration of this floss, demonstrates this product not only violates fda guidelines concerning use of pfas but also demonstrates the glide brands of p&g floss constitute and acute exposure hazard and does not merely threaten the health of habitual users of the product.The question below asks if i have the product in case the fda needs to evaluate it.My answer is that the prosthodontist office where i had my dental cleaning likely has many/a volume of it in stock and readily on hand.

• Brand Name: ORAL-B GLIDE PRO HEALTH
• Common Device Name: FLOSS, DENTAL
• Manufacturer (Section D): PROCTER & GAMBLE
• MDR Report Key: 17926000
• Report Number: MW5146885
• Device Sequence Number: 3295887
• Product Code: JES
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/08/2023

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?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Hispanic
• Patient Race: White