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	Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis (pd) patient contacted fresenius customer service to report that island dressing makes him itch when he wears it and irritates his skin.
Additional Manufacturer Narrative
This event was initially reported to the fda via voluntary medwatch mw5169204.This report is to acknowledge receipt of the medwatch form, received by amd medicom on may 6, 2025.Since no lot number was provided, a thorough investigation cannot be performed.The manufacturer confirmed that there was no change on used adhesive, manufacturing technology was found.The adhesive grammage, peeling strength were all checked before the release.Skin pasting test for this complained on different body part of different people, and these people move normally, and no abnormity was found after 24 hours pasting test.Therefore, no root cause could be determined, and the manufacturer states that this event could be related with use condition, pasting time, pasting method, pasting position and personnel skin status.The biocompatibility test was rechecked for this product, and the results are pass.

• 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: 21995870
• Report Number: 9611959-2025-00007
• Device Sequence Number: 4312009
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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