MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER FIX

Model Number	802500001
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sample is not available for return.A follow-up report will be submitted once investigation has been completed.
Event or Problem Description
The customer wonder if we have made any changes to our skatefix? they had 6 patients that have received blisters and become very red under the skaterfix after a couple of weeks.There was no leakage from the nephrostomy.This have happened during the last two month( nov/ dec) have we change anything in production?.
Additional Manufacturer Narrative
The lot number was not provided, so the manufacturing and inspection records could not be reviewed.According to the product experience report, sample not available to returned and the complaint was not confirmed, so no corrective action is required at this time.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.
Event or Problem Description
The customer wonder if we have made any changes to our skatefix? they had 6 patients that have received blisters and become very red under the skaterfix after a couple of weeks.There was no leakage from the nephrostomy.This have happened during the last two month( nov/ dec) have we change anything in production?.

• Brand Name: SKATER FIX
• Common Device Name: SKATER FIX
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 16186187
• Report Number: 0001625425-2023-00936
• Device Sequence Number: 2661065
• Product Code: KGZ
• UDI-Device Identifier: 00886333217618
• UDI-Public: 00886333217618
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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: 09/24/2025
• Device Model Number: 802500001
• Device Catalogue Number: 802500001
• Device Lot Number: 2240034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown