MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; OPTIVIEW, SACRUM, 9"X9"

Catalog Number	MSCOV99EP
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Skin Inflammation/ Irritation (4545)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "i have a new wound that the rn is attributing to the use of the optiview.".
Additional Manufacturer Narrative
The customer reported issue was "skin irritation" with optiview, sacrum, 9"x9", and the customer stated the optiview was "likely used inappropriately over a possible dtpi that was evolving prior to dressing being applied, or erythema that evolved"; the patient was "discharged" and the wound was "showing improvement".The investigation confirmed the reported issue with photo evidence.Without the sample, medline was unable to identify a root cause for the reported issue; as the lot number was not provided, a vendor investigation was not possible due to the product being sourced from multiple vendors.The complaint was documented for tracking and trending purposes and closed, with the division continuing to monitor trending through quarterly trend reports.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: OPTIVIEW, SACRUM, 9"X9"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883387
• Report Number: 1417592-2026-49823
• Device Sequence Number: 10707864
• Product Code: NAD
• UDI-Device Identifier: 10193489036190
• UDI-Public: 10193489036190
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/22/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MSCOV99EP
• 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: 03/26/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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