MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DRESSING,ALGINATE,CAL,MAXORB-EXTRA,4X4

Catalog Number	MSC7044EP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Subclinical Infection (2247)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that "after the alginate dressing was removed my wound appeared green in color.The nurses were discussing whether it was infected.One of the nurses thought maybe the green was healing it, while the other nurse thought it looked infected, and again, my new skin was gone.I was prescribed amoxicillin".The product used has not been confirmed as part of a recall as no lot number has been provided at this time.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
"burning sensation which led to a serious infection".
Additional Manufacturer Narrative
Updated information a2, a3, a4, g6, h2.

• Common Device Name: DRESSING,ALGINATE,CAL,MAXORB-EXTRA,4X4
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21356017
• Report Number: 1417592-2025-00065
• Device Sequence Number: 15388817
• Product Code: NAC
• UDI-Device Identifier: 10080196296842
• UDI-Public: 10080196296842
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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 Catalogue Number: MSC7044EP
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 10/24/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 77 KG