MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP OPTIFOAM GENTLE EX; OPTIFOAM GENTLE EX, SACRUM,7X7,

Catalog Number	MSCEX77EP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer informed and reported that he had an allergic reaction to foam dressing.Customer informed he got blisters and open sores.
Additional Manufacturer Narrative
Medline industries, lp, as the manufacturer, has already reported the adverse event (mrf.Report #:1417592-2026-00104).Shanghai iso medical products co., ltd., as the contract manufacturer, has cooperated with the customer in the investigation.We are conducting an investigation and will take corrective and preventive measures if necessary.

• Brand Name: OPTIFOAM GENTLE EX
• Common Device Name: OPTIFOAM GENTLE EX, SACRUM,7X7,
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer (Section G): SHANGHAI ISO MEDICAL PRODUCTS CO., LTD.; 999 liu chen rd,; pudong new area; shanghai, 20120 2; CH 201202
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24504964
• Report Number: 3004022422-2026-00001
• Device Sequence Number: 21322202
• Product Code: NAD
• UDI-Device Identifier: 10888277652651
• UDI-Public: 10888277652651
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: MSCEX77EP
• Device Lot Number: RX14725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2025
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 50 KG