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

Catalog Number	MSCEX99EPZ
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they were "having some issues with the optifoam gentle products tearing patient's skin and causing patients to have to extend their stays.".
Additional Manufacturer Narrative
The reporter described issues with optifoam gentle products tearing patient's skin, complaints about the dressings being too aggressive, and one patient with a skin tear/fissure in his gluteal fold who was told that the dressing caused the issue and that it was holding moisture.A call tag was sent, but no samples are available; without a sample or lot number, a more thorough investigation could not be conducted, and the supplier completed review of last 12 months of batch records and found no abnormalities.The customer reported issue could not be confirmed as no sample was received for investigation.Root cause could not be determined; based on the complaint initiation, it appears that this may be related to improper application but without the samples, this couldn't be confirmed, and no adverse trending was identified.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: OPTIFOAM GENTLE EX, SACRUM, 9X9
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50841258
• Report Number: 1417592-2026-46295
• Device Sequence Number: 15967622
• Product Code: NAD
• UDI-Device Identifier: 20888277652665
• UDI-Public: 20888277652665
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MSCEX99EPZ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown