MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. DUAL FLOSS; FLOSS, DENTAL

Model Number 2008T

Device Problem Insufficient Information (3190)

Patient Problems Angina (1710); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Vomiting (2144); Wheal(s) (2241); Urticaria (2278); Discomfort (2330); Syncope/Fainting (4411); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Date 10/14/2022

Event Type  Injury  

Event Description

Consumers wife stated she had purchased the dual defence green tea minty floss.She started to floss and noticed her gums were swollen, then it expanded to her lips.Her mouth felt very weird, her whole body had welts and her skin turned very red, with itchy and burning sensations.She tried flushing her mouth with water, but felt too sick, threw up and even fainted.The ambulance was called within 20 minutes and her chest had tighten.Paramedics said it was a 'classic anaphylactic allergy' and gave her benadryl and an epi-pen.She is now fine and did not have to use a 2nd dose of epi-pen.

Manufacturer Narrative

Please see attachments for additional information that has been received.

Event Description

Consumers wife stated she had purchased the dual defence green tea minty floss.She started to floss and noticed her gums were swollen, then it expanded to her lips.Her mouth felt very weird, her whole body had welts and her skin turned very red, with itchy and burning sensations.She tried flushing her mouth with water, but felt too sick, threw up and even fainted.The ambulance was called within 20 minutes and her chest had tighten.Paramedics said it was a 'classic anaphylactic allergy' and gave her benadryl and an epi-pen.She is now fine and did not have to use a 2nd dose of epi-pen.

• Brand Name: DUAL FLOSS
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): SUNSTAR AMERICAS INC.; 301 east central road; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR AMERICAS INC.; 301 east central road; schaumburg IL 60195
• Manufacturer Contact: monica jadczak ; 301 east central road; schaumburg, IL 60195 ; 8477944229
• MDR Report Key: 15649376
• MDR Text Key: 302163276
• Report Number: 0001413787-2022-00339
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A#S-P#N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

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 Model Number: 2008T
• Device Catalogue Number: N/A
• Device Lot Number: 2052D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female