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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS; INTERDENTAL BRUSH
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SUNSTAR AMERICAS, INC. GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS; INTERDENTAL BRUSH Back to Search Results
Model Number 872RQ
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/11/2024
Type of Reportable Event Malfunction
Event or Problem Description
A home health care worker who called for her client.Client used go between cleaner and the tip broke off and she swallowed it.She could breath, eat, drink and swallow but can still felt the tip in her throat.Follow up: care taker called back to say that consumer had an xray and it showed that it had passed.Nothing else to be done.
 
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Brand Name
GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS
Common Device Name
INTERDENTAL BRUSH
Manufacturer (Section D)
SUNSTAR AMERICAS, INC.
301 e. central road
schaumburg IL 60195
Manufacturer (Section G)
SUNSTAR AMERICAS, INC.
301 e. central road
schaumburg IL 60195
Manufacturer Contact
priya bhatia
301 e. central road
schaumburg, IL 60195
5514048470
MDR Report Key20728913
Report Number1413787-2024-00159
Device Sequence Number12999359
Product Code EFW
UDI-Device Identifier00070942002448
UDI-Public00070942002448
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number872RQ
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/11/2024
Initial Report FDA Received Date11/19/2024
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Usage of Device A
Patient Sequence Number1
Patient SexUnknown
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