MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LAP,GRASP,ATRAUM,SLIDE LOCK,ROT,5MM,35CM

Catalog Number	MDS527333SP
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: LAP,GRASP,ATRAUM,SLIDE LOCK,ROT,5MM,35CM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: felipe bifareti
• MDR Report Key: 50716672
• Report Number: 1417592-2026-35996
• Device Sequence Number: 13224823
• Product Code: HET
• UDI-Device Identifier: 10884389959367
• UDI-Public: 10884389959367
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K925079
• 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): 09/06/2026

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: MDS527333SP
• Device Lot Number: 0624
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/04/2024
• 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: 10/29/2024
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown