MAUDE Adverse Event Report: Medline Industried LP MEDLINE; WC,K1,18",FLPA,SA, 300 LB

Catalog Number	K1186N13S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: WC,K1,18",FLPA,SA, 300 LB
• Manufacturer (Section D): Medline Industried LP; three lakes dr; northfield IL 60093 -275
• Manufacturer Contact: leann gifford ; three lakes dr; northfield, IL 60093--275
• MDR Report Key: 50216357
• Report Number: 1417592-2026-08533
• Device Sequence Number: 20358348
• Product Code: IOR
• UDI-Device Identifier: 10193489001020
• UDI-Public: 10193489001020
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K232230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: K1186N13S
• Device Lot Number: 73625060001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown