Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TTBIO CORP. HENRY SCHEIN; HANDPIECE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TTBIO CORP. HENRY SCHEIN; HANDPIECE Back to Search Results
Model Number PRO 2-N SLIDE LATCH HEAD
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2023
Event Type  malfunction  
Event Description
Head part of device fell apart into patient's mouth during removal of decay.
 
Event Description
Head part of device fell apart into patient's mouth during removal of decay.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HENRY SCHEIN
Type of Device
HANDPIECE
Manufacturer (Section D)
TTBIO CORP.
2f., no.7, 6th road
industry park
taichung, twn 40755
TW  40755
Manufacturer (Section G)
TTBIO CORP.
2f., no.7, 6th road
industry park
taichung, 40755
TW   40755
Manufacturer Contact
jun li
2f., no.7, 6th road
industry park
taichung, 40755
TW   40755
MDR Report Key17639079
MDR Text Key322146674
Report Number3010364969-2023-00004
Device Sequence Number1
Product Code EGS
UDI-Device Identifier00304040126424
UDI-Public0100304040126424
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported2
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPRO 2-N SLIDE LATCH HEAD
Device Catalogue Number570-1766
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received08/25/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/17/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
-
-