MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER FIX; WEARABLE PERCUTANEOUS CATHETER/TUBE HOLDER

Model Number	802500001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user of the device reports an allergic reaction that started from using the product.Later the reaction developed in an infection and was treated.The user does not have the device anymore but provided pictures of the skin reaction.
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
We were unable to review the manufacturing and inspection records for this lot as the lot number was not provided.Additionally, no sample was returned for evaluation.However, the images shared with us indicate a reaction to an unidentified substance.Since we did not receive the device for analysis, we were unable to conduct a comprehensive investigation.However, please note that the skater fix device is manufactured in accordance with iso 10993 standards for biocompatibility.Since we do not have a device available for evaluation, we are unable to determine the root cause or identify a corrective action at this time.However, if the sample is returned in the future, we will be happy to revisit this complaint for further assessment.Additional information provided in h6 and h11.

• Brand Name: SKATER FIX
• Common Device Name: WEARABLE PERCUTANEOUS CATHETER/TUBE HOLDER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 21634210
• Report Number: 0001625425-2025-00971
• Device Sequence Number: 9276750
• Product Code: KGZ
• UDI-Device Identifier: 00886333217618
• UDI-Public: 00886333217618
• 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: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 802500001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 83 KG