MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC ORIGO; LOFRIC ORIGO TIEMANN 40CM CH14

Model Number	44414
Medical Device Problem Codes	Product Quality Problem (1506); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Genital Bleeding (4507)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch documentation and production data could not be reviewed since no lot number were reported.The patient has not reported any lot number and will not return any products for investigation.No images were sent either.It is not possible to verify that the catheters were in fact sharp and contributed to the bleeding and/or uti.The patients low blood pressure was identified at urgent care.The blood pressure continued to go up and down for about 4-5 days.It is not confirmed that this is related 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
Male patient, that has been using catheters for a long time.Recently switched from straight tip to coude tip.Recently he had two episodes of bleeding, the two episodes happened within two weeks time.The first bleeding lasted a day and self resolved.The second time, the patient experienced bleeding during each time he catheterized during four days straight, only during catheterization, not before or after.On the fourth day, which was january 25th, the patient went to urgent care.The bleeding had then resolved and no bleeding has occured since.When he went to urgent care, he also experienced fever and irregular heart rate.He was diagnosed with uti and treated with iv antibiotics.On january 30th the patient was discharged from the hospital.He says that his blood pressure is okey now and that he is feeling okey but not great.Patient wants to switch to another catheter brand.The patient described the catheter tip as too sharp and that it scratches the urethra.He says this was a general complaint about the coude tip and not specific for any batch.Also, he mentioned that the coude indicator ridge is offset and that it is hard to remember to check the specific orientation.The patient has not reported any lot number.

• Brand Name: LOFRIC ORIGO
• Common Device Name: LOFRIC ORIGO TIEMANN 40CM CH14
• 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: 24290016
• Report Number: 3009632672-2026-00002
• Device Sequence Number: 13343248
• Product Code: EZD
• UDI-Device Identifier: 07333387043432
• UDI-Public: 07333387043432
• Combination Product (Y/N): N
• PMA/510(K) Number: K250659
• 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): 02/09/2026

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: 44414
• Device Catalogue Number: 4441440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization
• Patient Sex: Male