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); Rash (2033)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was initially reported to the fda via voluntary medwatch mw5167457.No thorough investigation could be conducted without lot number and samples.However, the manufacturer confirmed that there is no change on used adhesive and on manufacturing technology.The adhesive grammage and the peeling strength are checked before the release.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 personal skin status.
Event or Problem Description
A caregiver of a peritoneal dialysis (pd) patient contacted customer service to report the patient was allergic to the 4x4, island dressing, sterile that they received recently.Patient had rash on the skin.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• 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: 21670670
• Report Number: 9611959-2025-00002
• Device Sequence Number: 11867107
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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
• Device Model Number: A50044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 03/21/2025
• 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