MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC ORIGO; CATHETER, STRAIGHT

Model Number	44314
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device was not available to be returned to the manufacturer.Batch documentation and production data for the affected device has been reviewed and no deviations were registered on the released lot.No earlier complaints are registered for this lot.The patient has returned devices from the same lot as the used device.Those devices have been included in the investigation.All 120 returned devices were visually controlled, and no catheters were stuck in the package.The user's problem could not be repeated.The cause of this incident has not been possible to establish.The user also reported that he had a urinary tract infection.Common adverse reactions (>1/100) related to catheterization therapy includes urinary tract infection.This information is in the provided ifu, under section adverse reactions.
Event or Problem Description
The adverse event occurred outside us, in united kingdom.A male patient has been using, a sterile, single-use intermittent urinary catheter lofric origo nelaton (40 cm, ch14).On (b)(6) 2024, the patient contacted the manufacturer representative and reported that he had problems to get the device out of the packaging since the device was stuck in the package.The patient also reported that he has got an infection.

• Brand Name: LOFRIC ORIGO
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; mölndal, SE-43 121; SW SE-43 121
• Manufacturer Contact: anja bengtzelius ; aminogatan 1; p.o. box 14; mölndal, SE-43-121 ; SW SE-43121
• MDR Report Key: 21109566
• Report Number: 3009632672-2025-00001
• Device Sequence Number: 8719385
• Product Code: EZD
• UDI-Device Identifier: 07333387043333
• UDI-Public: 07333387043333
• Combination Product (Y/N): N
• PMA/510(K) Number: K122078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/11/2026
• Device Model Number: 44314
• Device Catalogue Number: 4431425
• Device Lot Number: 660203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male