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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. TECHNIQUE COMPLETE CARE TOOTHBRUSH; TOOTHBRUSH, MANUAL
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SUNSTAR AMERICAS INC. TECHNIQUE COMPLETE CARE TOOTHBRUSH; TOOTHBRUSH, MANUAL Back to Search Results
Model Number 591PH
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/07/2022
Event Type  malfunction  
Event Description
Consumer had used a toothbrush provided by their dentist and the bristles came out and also got stuck in their teeth.
 
Event Description
Consumer had used a toothbrush provided by their dentist and the bristles came out and also got stuck in their teeth.
 
Manufacturer Narrative
The corrections to the original mdr submitted are as follows: 1.Section a.1.- wrong patient id: (b)(6) was changed to (b)(6).2.Section d.1-2 - corrected the brand name.3.Section h.3.- the wrong code was selected.1069 (break) was changed to 2907 (detachment of device or device component).
 
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Brand Name
TECHNIQUE COMPLETE CARE TOOTHBRUSH
Type of Device
TOOTHBRUSH, MANUAL
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
cynthia culmo
301 east central road
schaumburg, IL 60195
8477944241
MDR Report Key13542276
MDR Text Key288480741
Report Number0001413787-2022-00017
Device Sequence Number1
Product Code EFW
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number591PH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/07/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexFemale
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