MAUDE Adverse Event Report: DeRoyal Industries, Inc. Algidex Ag®+ I.V. Dressing, 1" (3 cm) Disc, 4 mm opening; DRESSING, WOUND, DRUG

Model Number	46-IV22
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Purulent Discharge (1812); Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An end consumer reported through a medwatch, ""[site]" redness "[catheter site redness]"oozing brown liquid that dries hard around brand iv remodulin centralline exit site; ongoing irritation and discharge around central line exit area, brownish-gold discharge "[catheter site discharge]" ongoing irritation and discharge around central line exit area "[catheter site irritation]" ongoing irritation and discharge around central line exit area despite trying algidex antimircrobial disc and switching to iodine and alcohol dressing "[no therapeutic response]" not been using antimicrobial disc, nor stabilization device and using wash cloths with cerave to clean skin around exit site "[device use issue]"." within this complaint the deroyal part was listed as a co-suspect in the report.
Additional Manufacturer Narrative
An end consumer reported through a medwatch, ""[site]" redness "[catheter site redness]"oozing brown liquid that dries hard around brand iv remodulin centralline exit site; ongoing irritation and discharge around central line exit area, brownish-gold discharge "[catheter site discharge]" ongoing irritation and discharge around central line exit area "[catheter site irritation]" ongoing irritation and discharge around central line exit area despite trying algidex antimircrobial disc and switching to iodine and alcohol dressing "[no therapeutic response]" not been using antimicrobial disc, nor stabilization device and using wash cloths with cerave to clean skin around exit site "[device use issue]"." within this complaint the deroyal part was listed as a co-suspect in the report.Deroyal industries, inc.Requested return of the device, but it was listed as unavailable.No lot number of the device was provided.Because the lot number was not provided, a representative lot number was selected and reviewed.The device history record of this lot was rewviewed for in-process inspections, cleaning records, sterilization documentation, and final release records.Review of these records found no issues and found all specifications and procedures were followed.Routine monitoring controls were also reviewed.Monthly bioburden testing was reviewed and found to be within established acceptance criteria.The review of manufacturing records found no issues with viscosity, out-of-specification results, or process deviations.The medwatch states that the patient was not consistently utilizing the antimicrobial disc or stablization device and was cleansing the catheter site using wash clothes and over the counter products.No evidence could be found to link the reported redness, irritation, or discharge to a manufacturing, sterilization, packaging, material, or labeling defect.A complaint to sales ratio was conducted over the past years and found to be (b)(4).Root cause: because the product nor lot number were able to be returned and no manufacturig related root cause could be established.Corrective and preventive actions: because the root cause was not able to be established, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.This complaint is complete at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

• Brand Name: Algidex Ag®+ I.V. Dressing, 1" (3 cm) Disc, 4 mm opening
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): DeRoyal Industries, Inc.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DeRoyal Industries, Inc.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; +1(865)362-2106
• MDR Report Key: 50090501
• Report Number: 2320762-2026-00015
• Device Sequence Number: 16020213
• Product Code: FRO
• UDI-Device Identifier: 50749756590223
• UDI-Public: 50749756590223
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: Other
• Device Model Number: 46-IV22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2026
• Initial Report FDA Received Date: 07/30/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown