MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRESSING,STRATASORB,COMP,ISLAND,4"X4"

Catalog Number	MSC3044
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Rash (2033); Blister (4537)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stratasorb dressings are causing skin reactions including blistering and rashes in orthopedic patients.They also indicated there have been repeated incidents.
Additional Manufacturer Narrative
The account reported that the stratasorb dressings are causing skin reactions including blistering and rashes in orthopedic patients, and indicated there have been repeated incidents.A retrospective review of the complete complaint file was conducted, and the review confirmed that the originally assigned defect codes and cause codes remain appropriate.The reported problem could not be confirmed from the information provided; no new information, failure modes, or trends were identified, and no additional investigation is required.The cause code was documented as logged twice: see invest.Details, and complaints are monitored via the trend analysis procedure.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: DRESSING,STRATASORB,COMP,ISLAND,4"X4"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50886190
• Report Number: 1417592-2026-50290
• Device Sequence Number: 9826704
• Product Code: NAD
• UDI-Device Identifier: 10080196669417
• UDI-Public: 10080196669417
• Combination Product (Y/N): N
• 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): 09/23/2026

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: MSC3044
• Device Lot Number: 10324030004
• Was Device Available for Evaluation?: No
• 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: 01/14/2025
• 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