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

Model Number	41814
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This adverse event occurred in the usa.A female patient with multiple sclerosis has been using, several sterile, single-use intermittent urinary catheters, lofric elle (ch14).On (b)(6) 2025, the patient contacted the manufacturer representative and reported she had had several urinary tract infections (uti) and that several months earlier she also had been hospitalized due to a uti.The most recent uti occurred last week in (b)(6).Since (b)(6) the patient is daily taking antibiotic 250mg keflex.She further reported that she started cic in (b)(6) 2025 (due to urinary retention, neurogenic bladder) with lofric elle and developed a uti 2 weeks later.She saw a doctor, was hospitalized with cystitis, urine cultures were done, and she had antibiotic cipro for 3 days and then 2 days of another antibiotic.Then she was sent home with 5 days cipro to take by mouth.In total the patient used lofric elle for 6 months.The patient is now doing well.The patient has chosen to now use a device from another manufacturer.None of the devices used are available to be returned to the manufacturer, the patient threw them all away.
Additional Manufacturer Narrative
Since no lot number is available it is not possible to review the batch documentation.Examination of the device could not be carried out since none of the used devices were returned to the manufacturer.The patient reported that she had had several urinary tract infections and that she also had been hospitalized due to a urinary tract infection.The patient has now recovered and is doing well.Common adverse reactions (>1/100) related to the intermittent urinary catheterization therapy includes urethral trauma and urinary tract infection.This information is in the ifu, under section adverse reactions.The device lofic elle is sterilized by irradiation in accordance with iso 11137 "sterilization of health care products - radiation sterilization".Sterilization dose has been substantiated by dose auditing studies.Bio burden levels are routinely monitored and have been well within specification.We see therefore no reason to believe that any cause of infection could originate from the device.The cause of this adverse event has not been possible to establish, and the problem the patient had has not been possible to trace to the device.Should additional facts prompt us to alter or supplement any information of conclusions contained in this report, a follow-up report will be submitted.

• Brand Name: LOFRIC ELLE
• 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: 23013350
• Report Number: 3009632672-2025-00030
• Device Sequence Number: 21248987
• Product Code: EZD
• UDI-Device Identifier: 07333387024592
• UDI-Public: 07333387024592
• Combination Product (Y/N): N
• PMA/510(K) Number: K211212
• 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): 09/10/2025

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 Model Number: 41814
• Device Catalogue Number: 4181450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/10/2025
• 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 Age: 47 YR
• Patient Sex: Female