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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CVS ADVANCED CLEAN FLOSS PICKS; FLOSS, DENTAL
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CVS ADVANCED CLEAN FLOSS PICKS; FLOSS, DENTAL Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problems Abscess (1690); Unspecified Infection (1930); Laceration(s) (1946); Pain (1994)
Event Date 12/01/2017
Event Type  Injury  
Event Description
A female consumer reported using (b)(6) advanced clean floss picks that caused bleeding and pain, resulting in an oral abscess during the month of (b)(6) 2017.While using the product, she stated "your product cut my gum, which then bled profusely.I was in a lot of pain immediately".Bleeding continued so consumer went to dentist, who advised the consumer to see a "perinatologist".An unknown time lapsed before consumer visited the periodontist; the consumer stated she had an ".Abscess that was full blown which covered my whole tooth.This doctor scraped off the abscess and had it analyzed." the biopsy results reportedly took longer due to holidays.The consumer reported the infection became even more severe and she had difficulty eating and sleeping.In (b)(6) 2018, the consumer reported ".The doctor was able to stitch my wound after receiving the lab report".Medical records from the consumer were requested, but none have been received.
 
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Brand Name
CVS ADVANCED CLEAN FLOSS PICKS
Type of Device
FLOSS, DENTAL
Manufacturer Contact
prestige brands pv & safety
4615 murray place
lynchburg, VA 24502
MDR Report Key7922413
MDR Text Key122187476
Report Number0001719513-2018-00003
Device Sequence Number1
Product Code JES
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 09/13/2018
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
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/14/2018
Initial Date FDA Received10/01/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
DIAZEPAM; NORCO
Patient Outcome(s) Other;
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