MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC IZI FIBER; NON-ABSORBABLE SUTURE WITH NEEDLE,WHITE/BLACK

Model Number	HS159
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Malfunction

• Brand Name: IZI FIBER
• Common Device Name: NON-ABSORBABLE SUTURE WITH NEEDLE,WHITE/BLACK
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland, OR 97232
• MDR Report Key: 25763302
• Report Number: 3009681798-2026-00033
• Device Sequence Number: 15887951
• Product Code: GAT
• UDI-Device Identifier: 00840277407238
• UDI-Public: 00840277407238
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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 Model Number: HS159
• Device Lot Number: 26010833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown