MAUDE Adverse Event Report: PICOSURE

Model Number	100-7012-010
Medical Device Problem Code	Radiation Underexposure (3018)
Health Effect - Clinical Code	Blister (4537)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a second patient experienced blisters following a pigmentation treatment using picosure.First patient was reported in mdr# 1222993-2021-00043.
Additional Manufacturer Narrative
Blisters are an expected transient side effect.No medical intervention was reported.Blisters has resolved.During a device evaluation, technician confirmed that the energy was low and greater than 20% outside of specification.The device history record confirms that the product passed and met all requirements before releasing.Technician repaired the device.Since the energy was confirmed to be outside of the specification, this event is an aro (accidental radiation occurrence) and therefore reportable.

• Brand Name: PICOSURE
• Common Device Name: PICOSURE
• Manufacturer Contact: 5 carlisle road; westford, MA 01886
• MDR Report Key: 12805627
• Report Number: 1222993-2021-00044
• Device Sequence Number: 14618049
• Product Code: GEX
• UDI-Device Identifier: 00841494100001
• UDI-Public: (01)00841494100001(11)171212
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K210226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: 100-7012-010
• Device Catalogue Number: 105-7012-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female