MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER FIX

Model Number 802500001

Device Problems Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)

Patient Problems Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 01/10/2023

Event Type  Injury  

Manufacturer Narrative

Sample is not available for return.A follow-up report will be submitted once investigation has been completed.

Event 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?.

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 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
• Type of Device: 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
• MDR Text Key: 307512316
• Report Number: 0001625425-2023-00936
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00886333217618
• UDI-Public: 00886333217618
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other