MAUDE Adverse Event Report: E.M.S ELECTRO MEDICAL SYSTEMS S.A. AIR-FLOW HANDY 3.0 PERIO ; DENTAL ABRASIVE AIR JET SYSTEM

Model Number FT-221

Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problem Respiratory Distress (2045)

Event Date 05/05/2015

Event Type  Injury  

Event Description

The air flow product malfunctioned and released an abundance of powder which was inhaled by the pt.She coughed in distress for several minutes and was teary eyed.She reported that her chest felt heavy.According to the info provided by the dentist, the pt did not seek any medical treatment.

Event Description

This is a follow-up report to the event on (b)(6) 2015.

• 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 vuarpilliere 31; nyon 1260 ; SZ 1260
• Manufacturer (Section G): HU-FRIEDY MFG. CO.,INC.; 3232 north rockwell st.; chicago IL 60618
• Manufacturer Contact: 3232 north rockwell st.; chicago, IL 60618
• MDR Report Key: 5048906
• MDR Text Key: 24904488
• Report Number: 1416605-2015-00002
• Device Sequence Number: 1
• Product Code: EFB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 06/05/2015

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: Health Professional
• Device Model Number: FT-221
• Device Catalogue Number: FT-221#HF/A/001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2015
• Distributor Facility Aware Date: 05/06/2015
• Device Age: 9 MO
• Event Location: Other
• Date Report to Manufacturer: 06/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR