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

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

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The device was returned to our affiliate in ems (b)(4) for assessment.The device seems to work in accordance with specifications with no particular temperature increase.However, ems requested the return to (b)(4) to conduct further investigation on temperature of potential piece in contact with patient.Following the info requested by our distributor (b)(4) to the hygienist, the burn is located at the lower left tongue and cheek.During the procedure, the hygienist noticed swelling on lower lip.It seems that the tip did not appear to be hot, but the metal nosecone appeared to be very hot according to the hygienist.The device was on power setting 4.Thus, this info must be confirmed by deeper measurement on the device.The risk of burn with the tip has already been identified within our risk analysis tfr-107 and this could be related to a lack of irrigation and/or the position of the tip on the soft tissues (wrong use), but these hypothesis might be confirmed.

Event Description

Dr.(b)(6) stated that the patient called her (b)(6) 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 (b)(6) and she noted that there was a burn on the patient's lip.She prescribed the following treatment.Dr.(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 (b)(6) for f/u.The root planning procedure was performed by the hygienist.There were 2 f/u appointments on the (b)(6).During both visits, dr.(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 (b)(6) or allergies and the patient insisted that he did not.(b)(4).

• Brand Name: PIEZON 150
• Type of Device: P150
• Manufacturer (Section D): E.M.S. ELECTRO MEDICAL SYSTEMS S.A.; chemin de la vuarpilliere 31; nyon, 1260 ; SZ 1260
• Manufacturer Contact: virginie siloret ; chemin de la vuarpilliere 31; nyon 1260 ; SZ 1260 ; 1229944700
• MDR Report Key: 4401553
• MDR Text Key: 19372203
• Report Number: 3004096429-2014-00007
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial
• Report Date: 11/17/2014

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1