MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRAPE,EXTREMITY,89X128",ST,12/CS

Catalog Number	DYNJP8002
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿the white is the top of the velcro and the purple is the bottom of the velcro.When they pulled the top of the white velcro the purple strip created the hole.¿.
Additional Manufacturer Narrative
A complaint was received related to tearing, and the customer reported when they pull on the top of the hook and loop the drape tears.Photos and a video were returned by the customer; the photos show a hole along the drape next to the hook and loop, and the video shows the customer pulling on the top of the hook and loop the drape tearing.Based on the results of the investigation, medline was able to confirm the complaint issue and that the product failed to meet specifications.Without the sample medline was unable to determine the root cause, and without the lot number unable to identify the contract manufacturer; the complaint investigation objective has been met and no further investigation into the cause and complaint is warranted.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: DRAPE,EXTREMITY,89X128",ST,12/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50614986
• Report Number: 1417592-2026-32560
• Device Sequence Number: 10625826
• Product Code: PUI
• UDI-Device Identifier: 10080196740796
• UDI-Public: 10080196740796
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/02/2026

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: DYNJP8002
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• 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