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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: E.M.S ELECTRO MEDICAL SYSTEMS S.A AIR-FLOW® HANDY 3.0 PERIO; DENTAL ABRASIVE AIR JET SYSTEM
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E.M.S ELECTRO MEDICAL SYSTEMS S.A AIR-FLOW® HANDY 3.0 PERIO; DENTAL ABRASIVE AIR JET SYSTEM Back to Search Results
Model Number FT-221
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems Complaint, Ill-Defined (2331); Patient Problem/Medical Problem (2688)
Event Date 05/05/2015
Event Type  No Answer Provided  
Event Description
This is a follow-up report to the event on (b)(6) 2015.The air flow product malfunctioned and released an abundance of powder which was inhaled by the patient.She coughed in distress for several minutes and was teary eyed.She reported that her chest felt heavy.According to the information provided by the dentist, the patient did not seek any medical treatment.
 
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Brand Name
AIR-FLOW® HANDY 3.0 PERIO
Type of Device
DENTAL ABRASIVE AIR JET SYSTEM
Manufacturer (Section D)
E.M.S ELECTRO MEDICAL SYSTEMS S.A
chemin de la vuarpillière 31
nyon, 1260
SZ  1260
MDR Report Key5057126
MDR Text Key25035144
Report Number3004096429-2015-00004
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 Manufacturer
Reporter Occupation Other Health Care Professional
Report Date 06/05/2015,08/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Model NumberFT-221
Device Catalogue NumberFT-221#HF/A/001
Device Lot NumberOF-88-20196-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2015
Distributor Facility Aware Date05/06/2015
Device Age9 MO
Event Location Other
Date Report to Manufacturer06/04/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/04/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age61 YR
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