MAUDE Adverse Event Report: CLINICAL INNOVATIONS LLC. TRAXI PANNICULUS RETRACTOR

Model Number	PRS-1030
Health Effect - Clinical Codes	Peeling (1999); Skin Erosion (2075); Skin Burning Sensation (4540)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
"patient experienced two small areas of skin breakdown and discomfort upon removal of traxi.Peeling skin and burning in those areas when showering.".

• Brand Name: TRAXI PANNICULUS RETRACTOR
• Common Device Name: TRAXI
• Manufacturer (Section D): CLINICAL INNOVATIONS LLC.; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: kellie stefaniak ; 747 w 4170 w; murray, UT 84123 ; 8012606079
• MDR Report Key: 14211263
• Report Number: 1722684-2022-00002
• Device Sequence Number: 1840998
• Product Code: HDL
• UDI-Device Identifier: 00814247020345
• UDI-Public: 00814247020345
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2024
• Device Model Number: PRS-1030
• Device Lot Number: M44919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown