Device was used for treatment, not diagnosis.This report is for unknown listerine gentle gum care floss.Upc#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 8041101-2018-00034.The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
The consumer alleged after using listerine gentle gum care floss, his/her gums reacted violently and got very swollen.The consumer went to a periodontist, had a tissue biopsy and almost 5 months of treatments.Consumer also alleged the symptoms came back after reintroduced the product.Therefore the dentist alleged that the cinnamon in the dental floss caused the swollen gum.The consumer has not used the floss in 3 weeks and the swelling is improving.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 8041101-2018-00034.The same patient is represented in each medwatch.
|