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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TTBIO CORPORATION MASTER 3 HANDPIECE

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TTBIO CORPORATION MASTER 3 HANDPIECE Back to Search Results
Model Number MASTER 3 STANDARD PB
Device Problem Device Slipped (1584)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/08/2021
Event Type  Injury  
Event Description
The doctor was performing a procedure on the patient and the multi-fluted carbide bur came out of the highspeed and the patient swallowed it. The patient swallowed bur and the mcd wants him to go the er immediately. The patient sought treatment at the (b)(6). Although the dental office attempted to contact the patient, they were unable to reach them. The patient has not received any further treatment at the dental office.
 
Manufacturer Narrative
Root cause: root cause cannot be fully determined although it can be confirmed that the chuck failed product specifications.
 
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Brand NameMASTER 3
Type of DeviceHANDPIECE
Manufacturer (Section D)
TTBIO CORPORATION
2f., no.07
6th industry park
taichung, 40755
TW 40755
MDR Report Key13067758
MDR Text Key282736579
Report Number3010364969-2021-00002
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMASTER 3 STANDARD PB
Device Catalogue Number570-0486
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/22/2021 Patient Sequence Number: 1
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