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 Codes	Pain (1994); Peeling (1999)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "adhesive not sticking well on sacral ex.Some also vocalized that the adhesive is sticking too well in some cases and causing skin injury.".
Additional Manufacturer Narrative
The customer reported issue "not sticking" and "sticking too well" with optifoam gentle ex, sacrum, 9x9; per the facility, "patients are reporting pain with dressing removal and epidermis peeling off when peeling back the dressing," and the dressings were placed as a preventative measure and were being removed to check the skin underneath.Upon sample review, there were no abnormalities with the adhesion and silicone adhesive, and inspection records for this product were reviewed and the adhesion results met specifications.The customer reported issue could not be confirmed with the received sample.The cause was documented as not confirmed with received sample, no adverse trending identified, and this complaint is ok to close.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: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897545
• Report Number: 1417592-2026-50865
• Device Sequence Number: 14959063
• Product Code: NAD
• UDI-Device Identifier: 20888277652665
• UDI-Public: 20888277652665
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/24/2026

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
• Device Lot Number: RX15823
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2024
• 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: 03/27/2024
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown