MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. DUETTO MT; AESTHETIC AND DERMATOLOGICAL LASER

Catalog Number PCMS00300

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burn(s) (1757)

Event Date 03/03/2022

Event Type  malfunction  

Event Description

Facial burn (cosmetic impairment) during a hair removal treatment near the chin.

Manufacturer Narrative

The event concerns a device not cleared in the us.Anyway, as similar devices of the same family are cleared under k192160, we decided to report.During a hair removal treatment a burn on the patient chin occurred.We are monitoring the entity of the damage to check if it would heal with common medical treatments (creams) with or without leaving a permanent scar.The cause of the present event is still under investigation.

• Brand Name: DUETTO MT
• Type of Device: AESTHETIC AND DERMATOLOGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• Manufacturer (Section G): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• Manufacturer Contact: dario bandiera ; via acquedotto, 109; samarate, varese 21017 ; IT 21017
• MDR Report Key: 14110407
• MDR Text Key: 298803123
• Report Number: 3004378299-2022-00065
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/14/2022

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?: Yes
• Device Catalogue Number: PCMS00300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1