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

Model Number OAM001830

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Radiation Burn (1755)

Event Date 02/26/2022

Event Type  malfunction  

Event Description

A patient reported blisters after ipl treatment on abdomen and chest.

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
• Type of Device: 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
• MDR Text Key: 300646948
• Report Number: 3004378299-2022-00107
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 08033945935139
• UDI-Public: 08033945935139
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• 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
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2021
• 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