FDA Adverse Event Malfunction Summary report: N

INTERDENTAL-SOFT-PICKS

MDR report key: 13997752 · Received April 4, 2022

Report

Report Number
0001413787-2022-00069
Event Type
Malfunction
Date Received
April 4, 2022
Date of Event
March 7, 2022
Report Date
March 7, 2022
Manufacturer
SUNSTAR AMERICAS INC.
Product Code
JET
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NY, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

CONSUMER STATED SHE PURCHASED SOFT PICKS AND THE BRISTLES STARTED TO FALL OFF DURING USE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1240577 INTERDENTAL-SOFT-PICKS PICK, MASSAGING JET SUNSTAR AMERICAS INC. 650, 632

Patients

Seq Age Sex Outcome Treatment
1 Female