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

Model Number	41610
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Product problem occurred outside us, in great britan.Female patient using lofric sense, a sterile, single-use intermittent urinary catheter.The primary packaging contains a water sachet for lubricating the coating.Patient contacted us on december 11th.Patient states that when squeezing the sachet, the water burst out of the bottom of the primary package.This happened on six products.The patient did not use them but had other non-faulty products available that she could use.She discarded the six faulty catheters.No harm or health impact reported.
Additional Manufacturer Narrative
Batch documentation has been reviewed, and no relevant deviations were registered.No earlier complaints registered for this lot.Examination of product samples could not be carried out since the products were discarded by the patient.Investigation of production data made by the process manager does not show any problems that could be connected to this product problem.Without samples, the root cause for the customer's problem could not be determined.Production controls including inspection of welds at order start, shift start and every 60 minutes are in place to detect problems like these.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 SENSE
• 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: johanna lundqvist ; aminogatan 1; p.o. box 14; SW SE-43121
• MDR Report Key: 23865089
• Report Number: 3009632672-2025-00047
• Device Sequence Number: 11871703
• Product Code: EZD
• UDI-Device Identifier: 07333387021737
• UDI-Public: 07333387021737
• Combination Product (Y/N): N
• PMA/510(K) Number: K123751
• 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): 12/22/2025

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
• Device Model Number: 41610
• Device Catalogue Number: 4161025
• Device Lot Number: 671717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2025
• 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
• Patient Sex: Female