MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER FIX

Model Number	802500001
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When the operator will remove the skater¿ fix catheter fixation device from the patient's skin, they found it was hard to remove and they tried to slowly and gently and carefully, but still cause the patient redness, pain and skin defect so they suspect it was a faulty product.The returned of the faulty product from the hospital.
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
A review of the device history records and inspection records was conducted, and no similar concerns were found.One opened sample was returned for evaluation.Inspection of the product confirmed that the adhesive was strong.This product is purchased from a supplier.Scar-00205 was submitted to the supplier to investigate further.They will provide root cause and any corrective actions to be taken.This product is purchased from a supplier.A scar was submitted to the supplier to investigate further.They will provide root cause and any corrective actions to be taken.Additional information provided in h.6.And h.11.

• Brand Name: SKATER FIX
• Common Device Name: SKATER FIX
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 19685893
• Report Number: 0001625425-2024-01063
• Device Sequence Number: 8009413
• Product Code: KGZ
• UDI-Device Identifier: 00886333217618
• UDI-Public: (01)00886333217618(17)260718(10)2330032
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2026
• Device Model Number: 802500001
• Device Lot Number: 2330032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2024
• Supplement Date Received by Manufacturer: 03/29/2025
• Initial Report FDA Received Date: 07/06/2024
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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