MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC ORIGO; LOFRIC ORIGO 40 CM CH12

Model Number	44312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation of returned devices and review of production batch records showed no signs of deviations.There is no previous complaint reported on the same lot.Tests of coating sliperiness and coating friction, respectively, gave both results within specification limits.The most probably root cause is if subject device exposes to high humidity environment or leakage from sachet the catheter may stick to its package and the coating property will deteriorate.Further, as verified by clinical urology experts, the uti reported with this complaint is one of the lower urinary tract symptoms seen in patients with benign prostatic hyperplasia.The patient was diagnosed with bph which can cause uncomfortable urinary symptoms, such as infection.It can also cause bladder, urinary tract or kidney problems and sign of blood in urine which is well known by both the patients and healthcare professionals.In this case, the patient was diagnosed with bph, and this may have contributed to the uti.
Event or Problem Description
A male patient with benign prostatic hyperplasia received 2 boxes of intermittent urinary catheter, brand name: lofric origo 40cm ch12.The patient claimed that some catheters were somehow glued to its package and when they were activated with the wetting fluid (salt solution), the coating became very sticky and not evenly distributed across the catheter tube.The patient reported a urinary tract infection (uti), which he believes could possibly be due to this catheter.According to the complaint the patient needed two treatments, one with a general antibiotic and one with an specific antibiotic (15 days in total).The patient currently feels very well and has recovered after the two antibiotic treatments.No other harms or injuries has been reported by the patient for this complaint.

• Brand Name: LOFRIC ORIGO
• Common Device Name: LOFRIC ORIGO 40 CM CH12
• 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; molndal, SE-43 121; SW SE-43121
• Manufacturer Contact: emad ramzi ; aminogatan 1; molndal, se-43121 molndal ; SW
• MDR Report Key: 18500730
• Report Number: 3009632672-2023-00007
• Device Sequence Number: 18118146
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2024

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: 07/13/2025
• Device Model Number: 44312
• Device Catalogue Number: 4431285
• Device Lot Number: 644021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2023
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White