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

Catalog Number	MSC3044
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the stratasorb falls off even with proper wound/periskin cleansing with our skintegrity wound cleanser and skin prep application to the periwound after patting the area dry.".
Additional Manufacturer Narrative
The customer reported an issue that stratasorb falls off even with proper wound/periskin cleansing, skin prep application to the periwound, and patting the area dry.The supplier/quality team was notified, and a formal investigation reviewed dhr and batch records, inspection records, manufacturing process, raw material quality, equipment calibration and preventive maintenance, employee training, and retain sample review; all were found to meet required specifications.The reported issue regarding stratasorb falls off could not be confirmed with the received sample, and after sample evaluation no issue was found.The batch retained sample and peel strength test met the requirement of the product, and the investigation indicated no need for further action at this time.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: daniel soto ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915424
• Report Number: 1417592-2026-52000
• Device Sequence Number: 12206941
• Product Code: NAD
• UDI-Device Identifier: 10080196669417
• UDI-Public: 10080196669417
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/25/2026

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: 87524110019
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2025
• 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: 07/10/2025
• Initial Report FDA Received Date: 09/28/2026
• 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