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	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility, "the icu brought up the increase in hapis on the units and the use of the medline foams." per the customer contact, "the nurses reported the foams rolling, not as user friendly when lifted to inspect the tissue, etc." it was reported, "the new product was brought into the unit in april and the facility acquired 7 sacral hapis in 6 months" and "this resulted in wounds to patients and longer hospital stays." unspecified medical intervention was required.
Additional Manufacturer Narrative
According to the facility, "the icu brought up the increase in hapis on the units and the use of the medline foams." per the customer contact, "the nurses reported the foams rolling, not as user friendly when lifted to inspect the tissue, etc." it was reported, "the new product was brought into the unit in april and the facility acquired 7 sacral hapis in 6 months" and "this resulted in wounds to patients and longer hospital stays." unspecified medical intervention was required.The facility was unable to clarify the dates of incidents for the events.There was no further information.Due diligence has been completed.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample was requested for evaluation.No additional information is available.It has been determined that the reported event caused or contributed to a death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• 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
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50898217
• Report Number: 1417592-2026-10400
• Device Sequence Number: 17599671
• 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