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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TTBIO CORP ACCLEAN ULTRASONIC SCALER; HANDPIECE
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TTBIO CORP ACCLEAN ULTRASONIC SCALER; HANDPIECE Back to Search Results
Model Number ACCLEAN ULTRASONIC SCALER
Device Problems Use of Device Problem (1670); Insufficient Information (3190); Excessive Heating (4030)
Patient Problem Burn(s) (1757)
Event Date 08/16/2023
Event Type  Injury  
Event Description
A 33 year old hygiene assistant was cleaning the room following a hygiene appointment.When she picked up the insert she received a burn on her finger.The assistant did not need further medical attention, but item has potential to burn patients or other staff members.Both items are extremely hot after use.This happened on (b)(6) 2023 at 11:30 a.M.
 
Manufacturer Narrative
Amended the formal investigation report to show evaluation results, root cause of failure, and resulting actions.See attached document.
 
Event Description
A 33 year old hygiene assistant was cleaning the room following a hygiene appointment.When she picked up the insert she received a burn on her finger.The assistant did not need further medical attention, but item has potential to burn patients or other staff members.Both items are extremely hot after use.This happened on (b)(6) 2023 at 11:30 a.M.
 
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Brand Name
ACCLEAN ULTRASONIC SCALER
Type of Device
HANDPIECE
Manufacturer (Section D)
TTBIO CORP
2f, no. 7, 6th road
industry pa
taichung, 40755
TW  40755
MDR Report Key17799662
MDR Text Key324051016
Report Number3007007357-2023-00011
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/11/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/22/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberACCLEAN ULTRASONIC SCALER
Device Catalogue Number570-2771
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/11/2024
Distributor Facility Aware Date08/24/2023
Device Age1 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/11/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age33 YR
Patient SexFemale
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