MAUDE Adverse Event Report: KEY SURGICAL, LLC SKIN MARKER

Model Number SM300

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

Through follow-up with the user facility, it was disclosed that chloraprep solution was used on the patient's skin as a prep solution.The chloraprep solution contains a high percentage of isopropyl alcohol which can be used to remove the skin marker as stated in the instructions for use.The surgical skin marker instructions for use include the following language, "skin surface must be clean and dried before marking skin.Mark the desired areas on intact skin with the skin marker according to facility protocol.Allow the markings to dry thoroughly before prepping.Prepare and apply prep solution as instructed by prep solution manufacturer.Markings may fade slightly but remain legible.Remove markings with isopropyl alcohol if desired.Markings will disappear naturally with bathing in a few days." it is likely that the use of the chloraprep solution allowed the skin marker to rub off of the patient's skin.The user facility was provided with a copy of the instructions for use.The device history record was reviewed, and no abnormalities were noted.There have been no other complaints associated with this lot.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that at the beginning of a patient procedure, it was noted that the ink from their skin marker that was used to draw on the patient prior to the procedure had rubbed off of the patient's skin.The markings had to be redrawn resulting in a procedure delay.The procedure was completed successfully.No report of injury.

• Brand Name: SKIN MARKER
• Type of Device: SKIN MARKER
• Manufacturer (Section D): KEY SURGICAL, LLC; 8101 wallace road; eden prairie MN 55344
• Manufacturer (Section G): KEY SURGICAL, LLC; 8101 wallace road; eden prairie MN 55344
• Manufacturer Contact: coletta cohara ; 8101 wallace road; eden prairie, MN 55344 ; 4403586251
• MDR Report Key: 17602759
• MDR Text Key: 321734952
• Report Number: 2183785-2023-00002
• Device Sequence Number: 1
• Product Code: FZZ
• UDI-Device Identifier: 00849771030485
• UDI-Public: 00849771030485
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SM300
• Device Lot Number: 21040701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1