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

Model Number	44312
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Genital Bleeding (4507)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch documentation and production data have been reviewed and no relevant problems or deviations were registered.No earlier complaints registered for this lot.The user has discarded the sharp catheters and he has no more of the same lot to send back.He will not disclose any more information about his medical history, medication etc and did not take any pictures of the products.It is not possibly to verify that the catheters where in fact sharp and contributed to the bleeding.With this limited information, and with no products returned, at this point it is not possible to establish any root cause.Should additional facts prompt us to alter or supplement any information of conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
Adverse event occurred outside us, in great britain.Male patient reported that 5-6 of his catheters recently felt like they had sharp ridges on them.After using one of the catheters, he disinfected it and examined it by hand.He describes that he could feel like a "chisel mark".On two occasions he experienced minor bleeding after using catheters that he perceived as sharp.He did not seek any medical attention and has recovered well.

• 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: johanna lundqvist ; aminogatan 1; p.o. box 14; mölndal, SE-43-121 ; SW SE-43121
• MDR Report Key: 22335863
• Report Number: 3009632672-2025-00017
• Device Sequence Number: 18423407
• Product Code: EZD
• UDI-Device Identifier: 07333387043319
• UDI-Public: 07333387043319
• 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): 06/26/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 44312
• Device Catalogue Number: 4431225
• Device Lot Number: 663600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2024
• 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
• Patient Sex: Male