MAUDE Adverse Event Report: Medline Industries, LP Optifoam Gentle EX; OPTIFOAM GENTLE EX, SACRUM, 9X9

Catalog Number	MSCEX99EP
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury

• Brand Name: Optifoam Gentle EX
• Common Device Name: OPTIFOAM GENTLE EX, SACRUM, 9X9
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50903487
• Report Number: 1417592-2026-10423
• Device Sequence Number: 13439914
• Product Code: NAD
• UDI-Device Identifier: 10888277652668
• UDI-Public: 10888277652668
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MSCEX99EP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/25/2026
• 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 Sex: Unknown