MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC ORIGO; LOFRIC ORIGO TIEM 40CM CH16

Model Number	44416
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The production of lofric origo tiemann is a complex procedure where two different plastic materials are merged.It's not possible to have the ridge ending up in an exact position due to two completely different material properties (of tube and funnel).To ensure a proper and safe insertion of the tiemann catheter tip, the instruction for use (ifu) clearly states that the user must align the angle of the bent catheter with the ridge on the funnel before insertion.The ifu for lofric origo tiemann explains, both with text and image, that the user shall "individually inspect and align the indicator".Wellspect's clinical nurse team have informed us that ic users normally compensate for a misalignment of the indicator and that the curve of the bent tip is what will steer how to insert the catheter (rather than relying only on the ridge on the funnel).The lofric origo user in the current situation could potentially have missed following the outlined instructions to ensure that the bent tip was inserted in the correct angle.He experienced bleeding, which sometimes happen when passing by the prostate in older men since an enlarged prostate becomes more easily bleeding.We do not consider the current situation to be caused by a faulty product, rather it's an effect of the behavior when inserting the catheter with a bent tip.
Event or Problem Description
A 73-year-old man has been using lofric origo with tiemann (coude) tip due to problems with urinary retention (neurogenic bladder) as well as enlarged prostate.The user experienced blood in the urine and on the tip of the catheter after use.He sought medical attention and had a urine culture done to determine the bacteria count.To treat a urinary tract infection (uti), he was prescribed antibiotics 3 times daily for 14 days.In addition, he will take low dose antibiotic 1 times daily indefinitely to further reduce risks of uti's.No other testing, procedures, or treatments were performed.According to the patient the harm is related due to misalignment between the catheter bent tip and the indicator on the catheter funnel which has scored his urethra and let to uti.

• Brand Name: LOFRIC ORIGO
• Common Device Name: LOFRIC ORIGO TIEM 40CM CH16
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o. box 14, mölndal, sweden SE-43-121 ; SW SE-43121
• MDR Report Key: 21109464
• Report Number: 3009632672-2025-00002
• Device Sequence Number: 20698724
• Product Code: EZD
• UDI-Device Identifier: 07333387043456
• UDI-Public: 07333387043456
• 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): Unknown
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/08/2026
• Device Model Number: 44416
• Device Catalogue Number: 4441640
• Device Lot Number: 655469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male