MAUDE Adverse Event Report: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. PIEZON 150; P150 PIEZON 150

Model Number FT-223

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 10/14/2014

Event Type  Injury  

Event Description

(b)(6) stated that the patient called her tuesday stating that his lip was swollen and he was in pain after the unit was used on him.She had him come to the office for f/u on friday and monday and she noted that there was a burn on the patient's lip.She prescribed the following treatment.(b)(6) gave the patient advil for swelling and tylenol 3 with codeine for pain to be taken in intervals.I.E.Take #3 then next time take the advil and the patient is scheduled to come to her office on friday for f/u.The root planning procedure was performed by the hygienist.There were 2 f/u appointments on the friday and monday.During both visits, (b)(6) asked the patient to make an appt with their physician for additional f/u but the patient refused and insisted that the issue had improved.The doctor's office took photos of the burns at every f/u visit.The hygienist has asked the patient if he had any history of herpes or allergies and the patient insisted that he did not.Mfr ref#: 3004096429-2014-00007.

• Brand Name: PIEZON 150
• Type of Device: P150 PIEZON 150
• 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: 4356206
• MDR Text Key: 5198840
• Report Number: 1416605-2014-00007
• Device Sequence Number: 1
• Product Code: ELC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/26/2014

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-223
• Device Catalogue Number: FT-223#HF-/A/001
• Device Lot Number: DP041804
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/26/2014
• Distributor Facility Aware Date: 10/30/2014
• Device Age: 11 MO
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 86