MAUDE Adverse Event Report: EL. EN. ELECTRONIC ENGINEERING SPA ELITE IQ

Catalog Number 105-7041-003

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

Patient Problem Blister (4537)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported that patient experienced blisters following a laser hair reduction treatment using elite iq.Five days post treatment patient went swimming and afterwards felt irritation and noticed blisters outside of the treatment area.Patient was instructed to use aloe vera as preventative medication.Patient also reported visiting a hospital but did not provide any additional detail regarding visit.The device was evaluated and found to be operating as intended within specification.Cynosure's clinical team investigated the event and was unable to determine if blister was caused by elite iq treatment.Clinical states "larger blister may have been caused by friction." root cause is unknown and since clinical investigation was inconclusive, cynosure will continue to monitor such complaints.Additional investigation was performed by cynosure medical director who determined scarring is likely.Blisters are expected side effects from laser treatments, however permanent scarring is a likely outcome and therefore reportable.

• Brand Name: ELITE IQ
• Type of Device: ELITE IQ
• Manufacturer (Section D): EL. EN. ELECTRONIC ENGINEERING SPA; via baldanzese 17; calenzano 50041 ; IT 50041
• MDR Report Key: 18985695
• MDR Text Key: 338691616
• Report Number: 1222993-2024-00013
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 08034108510880
• UDI-Public: (01)08034108510880(11)220906
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 105-7041-003
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2024
• Distributor Facility Aware Date: 02/26/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/27/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Sex: Female