MAUDE Adverse Event Report: AMD MEDICOM INC. RITMED NON-WOVEN ISLAND DRESSING; WOUND DRESSING

Model Number	A50044
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was initially reported to the fda via voluntary medwatch mw5168908.This report is to acknowledge receipt of the medwatch form, received by amd medicom on april 24, 2025.The investigation is ongoing.
Event or Problem Description
A peritoneal diatysis (pd) patient contacted fresenius mecical care to report that the patient had an allergic reaction to the island dressings.He first started using them two weeks ago.The skin around his catheler was red, bumpy and itchy.They went to see a dermatologist and he suggested they stop using the island dressings.Once they stopped using them his skin improved.The patient involvement is unknown however there was no harm or adverse event reported.

• Brand Name: RITMED NON-WOVEN ISLAND DRESSING
• Common Device Name: WOUND DRESSING
• Manufacturer (Section D): AMD MEDICOM INC.; 2555 chemin de l'aviation; pointe-claire; montreal, quebec H9P 2 Z2; CA H9P 2Z2
• Manufacturer (Section G): ALLMED MEDICAL PRODUCTS CO., LTD; 19f, block a, taurus plaza; no.8 taoyuan road; nanshan district, shenzhen 51805 5; CH 518055
• Manufacturer Contact: franca mancino ; 2555 chemin de l'aviation; pointe-claire; montreal, quebec H9P 2-Z2 ; CA H9P 2Z2
• MDR Report Key: 21953019
• Report Number: 9611959-2025-00006
• Device Sequence Number: 21041920
• Product Code: KGX
• UDI-Device Identifier: 10686864051203
• UDI-Public: 10686864051203
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: Lay User/Patient
• Device Model Number: A50044
• Device Lot Number: 12870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/02/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown