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: MICRO DRILL SERIES ANGLED ATTACHMENT; UNIT, OPERATIVE DENTAL
  • 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
 

MICRO DRILL SERIES ANGLED ATTACHMENT; UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100015252
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 09/30/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device was not available for evaluation.Additional information: 1 device was not labeled for single-use.1 device was not reprocessed or reused.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device had a component detach.1 event had no patient involvement; no patient impact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MICRO DRILL SERIES ANGLED ATTACHMENT
Common Device Name
UNIT, OPERATIVE DENTAL
MDR Report Key12680139
Report Number3015967359-2021-02295
Device Sequence Number11821864
Product Code EIA
UDI-Device Identifier04546540391803
UDI-Public04546540391803
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/22/2021
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
Operator of Device No Information
Device Model Number5100015252
Device Catalogue Number5100015252
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/30/2021
Initial Report FDA Received Date10/22/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
-
-