MAUDE Adverse Event Report: SYNERON MEDICAL LTD. PROFOUND SYSTEM; ELECTROSURGICAL UNIT AND ACCESSORIES

Model Number	FG70514
Health Effect - Clinical Codes	Bruise/Contusion (1754); Burn(s) (1757); Peeling (1999); Scar Tissue (2060)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental mdr will be submitted upon the completion of the investigation.
Event or Problem Description
Customer reported to technical service that a (b)(6) year old female patient with fitzpatrick skin type ii- iii; positive for sun exposure, prior facial surgery, and scar tissue, received profound treatment on the lower face, submentum, and anterior and lateral neck on (b)(6) 2018.Treatment included use of subcutaneous cartridge, applying 68 degrees celsius for 4 seconds at a depth of 6 mm, followed by treatment with the handpiece at 68 degrees celsius for 3 seconds at a 4 mm depth.A total of 2546 pulses were delivered.Patient tolerated the procedure well and ice was applied.Patient reported excessive bruising, bleeding/seeping, pustules, peeling skin, and later reported that she had received several burns, which nurse practitioner referenced as a partial thickness wound and not a burn.The right cheek may have become infected and led to medical intervention/prescribed antibiotic cipro, which resulted in a scarred area on the right cheek as of (b)(6) 2019.
Additional Manufacturer Narrative
Customer declined a system evaluation and confirmed that the device is operating within specifications with no problems identified or experienced.The adverse event that occurred is not attributable to a device malfunction.No new risks or hazards identified with this complaint.Scarring is listed in the operators manual as a transient side effect that should clear with time.Will continue to monitor issue through tracking and trending activities.

• Brand Name: PROFOUND SYSTEM
• Common Device Name: ELECTROSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): SYNERON MEDICAL LTD.; inductrial zone po box 550; yokneam, illit 20692 ; IS 20692
• MDR Report Key: 8456969
• Report Number: 3003772750-2019-00001
• Device Sequence Number: 2926892
• Product Code: GEI
• UDI-Device Identifier: 07290109952444
• UDI-Public: 07290109952444
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

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
• Operator of Device: Health Professional
• Device Model Number: FG70514
• Device Catalogue Number: FG70514
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COQ L 0 (400 MG), QD; COZAAR (50 MG); DIAZEPAM TAB 5 MG PRN; METHYLPREDNISOLONE TAB 4 MG DOSE PACK; MINOCYCLINE HCI, PRN; MUPIROCIN (MUPIROCIN OINT 2%),3-4 QD FOR PRN; PRAVACHOL (80 MG), QD; PREDNISONE, 2-4 MG QD; PRN LUNESTA (3 MG), PRN; QD DEXILANT (60 MG)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR