MAUDE Adverse Event Report: COLGATE PALMOLIVE COMPANY COL DENTAL FLOSS

Device Problems Material Fragmentation (1261); Physical Resistance/Sticking (4012)

Patient Problems Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This is a spontaneous report received on 15jun2021 by sales representative from dental office regarding a female patient (in her 20s) who stated that col dental floss was shredding and got caught up under the gums and she had infection.There was no relevant medical history provided.On an unspecified date in 2021 (a couple of months ago), patient started using col dental floss for good oral hygiene twice daily.Sales representative was informed that col dental floss shreds and it got caught up under patient's gums (a couple of months ago).On an unspecified date patient went to periodontist to remove the floss from under the gums and it caused an infection.The dental office person stated that the new colgate dental floss they are using in "the brown container" was also shredding.On an unspecified in 2021 patient stopped using col dental floss.At the time of this report, patient had recovered from the events.

• Brand Name: COL DENTAL FLOSS
• Type of Device: COL DENTAL FLOSS
• Manufacturer (Section G): COLGATE PALMOLIVE COMPANY; 909 river road; piscataway NJ 08854
• Manufacturer Contact: leonard humel ; 909 river road; piscataway, NJ 08854
• MDR Report Key: 12092556
• MDR Text Key: 259178830
• Report Number: 0002418748-2021-00001
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/15/2021

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 06/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other