MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. TWAIN IPL; INTENSE PULSED LIGHT DEVICE

Model Number	OAM001830
Health Effect - Clinical Code	Radiation Burn (1755)
Date of Event	02/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A patient reported blisters after ipl treatment on abdomen and chest.
Additional Manufacturer Narrative
A patient reported blisters on abdomen and chest during an ipl treatment.The device was checked and energy output was within specifications, we are waiting for further information from the distributor.

• Brand Name: TWAIN IPL
• Common Device Name: INTENSE PULSED LIGHT DEVICE
• 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: 14521012
• Report Number: 3004378299-2022-00107
• Device Sequence Number: 5876760
• Product Code: GEX
• UDI-Device Identifier: 08033945935139
• UDI-Public: 08033945935139
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/27/2022

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 Model Number: OAM001830
• Device Catalogue Number: OAM001830.00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown