MAUDE Adverse Event Report: Moog Medical Devices Group Curlin Painsmart IOD IV Infusion Pump

Model Number	360-1300PE5L2
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	Lethargy (2560)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction

• Brand Name: Curlin Painsmart IOD IV Infusion Pump
• Common Device Name: Infusion Pump
• Manufacturer (Section D): Moog Medical Devices Group; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): Moog Medical Devices Group; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer Contact: kristin egelhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; +1(801)264-1001
• MDR Report Key: 50144324
• Report Number: 1722139-2026-00209
• Device Sequence Number: 10730413
• Product Code: FRN
• UDI-Device Identifier: 10814844000365
• UDI-Public: 10814844000365
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K981816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/06/2026

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
• Operator of Device: Other
• Device Model Number: 360-1300PE5L2
• Device Catalogue Number: 360-1300PE5L2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2009
• 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 Age: 61 YR
• Patient Sex: Unknown