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

Model Number FG70514

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Edema (1820); Erythema (1840); Reaction, Injection Site (2442)

Event Date 02/28/2019

Event Type  Injury  

Event Description

Candela post market surveillance received a patient-reported voluntary medwatch (mw5085519) from the fda on 4/23/2019, indicating a patient reported having had profound-rf treatment to face on (b)(6) 2019 and experienced face becoming inflamed and swollen "twice the size" of normal and was told that was to be expected; patient went home with aquaphor ointment covering face.Patient observed presence of white pin-head sized raised bumps; and started applying over-the-counter hydrocortisone cream as directed by cosmetic doctor.Over the next 10 days, the redness and edema slowly decreased.Condition did not improve and doctor ordered triamcinolone 0.5% cream.Patient reported condition did not improve and started medrol 4 milligram dosepack.As of (b)(6) 2019, patient reports raised bumps on neck are less raised, but visible; left cheek has new bumps.No further information reported.No contact information is available for the patient, or for the clinic where the profound treatment was performed.

Manufacturer Narrative

Additional manufacturer narrative was inadvertently omitted on submission number 3003772750-2019-00004.The alleged device was not reported to or returned to manufacturer.It cannot be determined if the equipment was operating within specification because the account name and/or device serial number was not provided.Information on system settings/techniques is unavailable.Therefore, it is undeterminable if the customer used the correct system settings/technique as described in the treatment guidelines for the device in use.Review of the profound user manual reveals that any procedure perforating the skin can cause discomfort, pain, bleeding, infection, swelling, edema, scar formation, permanent marking and pigment alteration.Potential risks which could result from the profound treatment include discomfort during and after the procedure, pain, infection, scarring, swelling or edema, permanent discoloration, nerve damage, and/or loss of sensation.Additionally, treatment side effects may include focal edema or induration at treatment sites: focal edema at treatment sites typically develops 2 to 10 minutes follow treatment and can remain visible for 24 to 48 hours.Induration is often palpable for 5 to 10 days following treatment and has been reported by patients as persisting for 30 days.Therefore, the cause assigned to this event is known inherent risk of device indicating that the reported adverse event is known and documented in the labeling (including both short or long term known complications or adverse reactions).

• Brand Name: PROFOUND SYSTEM
• Type of Device: ELECTROSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): SYNERON MEDICAL LTD.; inductrial zone po box 550; yokneam, 20692 0; IS 206920
• MDR Report Key: 8603262
• MDR Text Key: 144814695
• Report Number: 3003772750-2019-00004
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K161043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FG70514
• Device Catalogue Number: FG70514
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AQUAPHOR OINTMENT; ARNICA MONTANA (PRE/POST PROCEDURE); BIOTIN; HYDROCORTISONE CREAM (OTC); MEDROL 4MG DOSE PACK; METOPROLOL SUCCINATE ER 25MG PO QD; MULTI-VITAMIN; TRIAMCINOLONE 0.5% CREAM; VITAMIN D; AQUAPHOR OINTMENT; ARNICA MONTANA (PRE/POST PROCEDURE); BIOTIN; HYDROCORTISONE CREAM (OTC); MEDROL 4MG DOSE PACK; METOPROLOL SUCCINATE ER 25MG PO QD; MULTI-VITAMIN; TRIAMCINOLONE 0.5% CREAM; VITAMIN D
• Patient Outcome(s): Other