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 Discoloration (2074); Blister (4537)
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis (pd) patient contacted fresenius customer service to report they have an allergic reaction with the use of the 4x4 island dressing, it leaves blisters, and discolors her skin.No further information was provided.
Additional Manufacturer Narrative
This event was initially reported to the fda via voluntary medwatch mw5168381.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.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.

• 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: 21864187
• Report Number: 9611959-2025-00003
• Device Sequence Number: 4606791
• Product Code: KGX
• UDI-Device Identifier: 10686864051203
• UDI-Public: 10686864051203
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 04/14/2025

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: 03/26/2025
• Initial Report FDA Received Date: 04/18/2025
• 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
• Outcome Attributed to Adverse Event: Congenital Anomaly
• Patient Sex: Unknown