MAUDE Adverse Event Report: Medline Industries, LP Medline; PROT.,STA.,PLUS,W/DRAPE,CLIP,PG

Catalog Number	64000945
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: PROT.,STA.,PLUS,W/DRAPE,CLIP,PG
• Manufacturer (Section D): Medline Industries, LP; 10 glens falls technical pk. d; glens falls NY 12801 -386
• Manufacturer Contact: martin posada ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50794842
• Report Number: 3015910259-2026-00174
• Device Sequence Number: 10516016
• Product Code: FPA
• UDI-Device Identifier: 10193489059021
• UDI-Public: 10193489059021
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K843726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 64000945
• Device Lot Number: 0000195899
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown