MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; OPTIFOAM GENTLE SA AG,POST-OP,4X10

Catalog Number	MSC97410
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "complaints of dressing not adhering well on patients even when skin is dry on dressing application" and "redness/skin reaction observation of redness under dressing on some patients.".
Additional Manufacturer Narrative
This is a combination product the customer reported dressing not adhering well on patients even when skin is dry on dressing application, dressing not staying in place, and redness/skin reaction with observation of redness under dressing on some patients; 2 staff applied dressings and noted skin irritation (redness only, no itching) after removal.The investigation evaluated a received sample, and the supplier reviewed batch records and confirmed that the item had been manufactured without any issues; the product has undergone biocompatibility testing per iso 10993 and has passed.The customer reported issue "redness/skin reaction" could not be confirmed with the received sample, and the product did not show any abnormalities.No root cause was identified; no adverse trending identified, and the complaint was 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 SA AG,POST-OP,4X10
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50855284
• Report Number: 1417592-2026-47678
• Device Sequence Number: 15941074
• Product Code: FRO
• UDI-Device Identifier: 30888277415380
• UDI-Public: 30888277415380
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K033732
• 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: MSC97410
• Device Lot Number: WO57764
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/07/2024
• 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: 05/07/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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