MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC HYDRO-KIT; LOFRIC HYDRO-KIT NELATON 40CM CH16

Model Number	42016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the batch documentation and production data revealed no deviations or other relevant issues.The (b)(4) unused catheters returned from the same lot were visually inspected, and no defects were identified.Ten of these samples were tested according to the internal test method "manual test of slipperiness and smoothness of catheter surface", and all resulsts were within specification.Based on the available information, no root cause could be identified.The investigation did not reveal any product-related deficiences, and no corrective or preventive actions are considered necessary at this time.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 germany.A 65-year-old male with a spinal cord injury, experienced in intermittent catheterization, reported that six (6) lofric hydro-kit catheters felt sharp-edged during use.He described the sensation as very uncomfortable in the urethra; it was not painful, but felt a slight friction.On one (1) occasion, a minor urtethral bleeding occurred when the catheter was withdrawn.The bleeding was transient and did not recur.The patient is currently taking acimethin and dridase.He has used additional lofric hydro-kit catheter after the incident without experiencing similar issues.Lofric hydro-kit is a sterile use urinary catheter.Each primary sterile package consists of a catheter, a water sachet (wetting solution bag) and a urine collection bag.The wetting solution bag is used to activate the hydrophilic catheter coating before use.

• Brand Name: LOFRIC HYDRO-KIT
• Common Device Name: LOFRIC HYDRO-KIT NELATON 40CM CH16
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; mölndal, SE-43 1 21; SW SE-431 21
• Manufacturer Contact: ulrika skogbäck ; aminogatan 1; p.o.box 14; mölndal, SE-43-1 21 ; SW SE-431 21
• MDR Report Key: 24755979
• Report Number: 3009632672-2026-00012
• Device Sequence Number: 9230150
• Product Code: EZD
• UDI-Device Identifier: 07333387042831
• UDI-Public: 07333387042831
• 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): 04/01/2026

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?: No
• Device Model Number: 42016
• Device Catalogue Number: 42016003
• Device Lot Number: 664677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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: Other
• Patient Sex: Male