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
Dressing caused "sores" on skin,.
Additional Manufacturer Narrative
It was reported that the user has extremely sensitive skin and has had skin reactions to other devices in the past.It was reported that the device caused burn like sores where it was placed.Due to this, the area required additional treatment and prolonged healing.It was reported that he visited the hospital for an unrelated issue where wound care was provided, as well as further treatment at home.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.

• 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 Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24313729
• Report Number: 1417592-2026-00104
• Device Sequence Number: 11971336
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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 Expiration Date: 05/26/2026
• 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: 01/15/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2025
• 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