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

Model Number	40012
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three products have been returned from the patient to the manufacturer.It was observed that the catheters had been pressed during packaging, and the welding of the packaging appeared incomplete or improperly performed, compromising the sterile barrier of the product.To assess whether this was a systemic or isolated problem, the following actions were taken: inspection of witness samples retained from the same lot.Review of batch manufacturing and packaging documentation.Verification of process parameters and recorded in process controls.No deviations, abnormalities, or trends were identified during this review.All documented process steps were performed according to the approved procedures, and the retained witness samples did not show similar defects.Based on the investigation, the issue was determined to be an individual, isolated case rather than a batch related or process related failure.
Event or Problem Description
The adverse event occurred outside us, in italy.A male patient has been using, a sterile, single-use intermittent urinary catheters lofric nelaton (40cm, ch12).On (b)(6) 2026, the patient contacted the manufacturer representative and reported that the end of the primary package was not sealed completely, compromising the sterile barrier of the product.The patient reported that he had used three products with this mal-function.Further the patient reported that he had discarded the used products and that he will return the remaining products to the manufacturer.The patient did not suffer any harm.

• Brand Name: LOFRIC
• Common Device Name: LOFRIC NELATON 40CM CH12
• 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-43 121
• MDR Report Key: 24468581
• Report Number: 3009632672-2026-00006
• Device Sequence Number: 9644240
• Product Code: EZD
• UDI-Device Identifier: 07333387033433
• UDI-Public: 07333387033433
• Combination Product (Y/N): N
• PMA/510(K) Number: K113424
• 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): 02/27/2026

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 Model Number: 40012
• Device Catalogue Number: 4001230
• Device Lot Number: 673184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2025
• 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: Male