MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC PRIMO; LOFRIC PRIMO NELATON MALE 40CM CH14

Model Number	41014
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has tried to get more information about the damaged products and received the answer from the patient that the products had been discarded and no photos were available.The patient sent a photo of the secondary package.The manufacturer discovered that the secondary package had been relabeled by a parallel importer.The concerned lot 670418 for this adverse event is connected to reference number 4101430.The parallel importer had over-labeled the correct reference number 4101430 with the incorrect reference number 4101425.Reference number 4101430 and 4101425 are the same model (41014) but the two last digits are different depending on intended market where 30 is for italy and 25 is for united kingdom.Batch documentation and production data have been reviewed, and no relevant problems or deviations were registered.No earlier complaints are registered for this lot.Examination of product samples could not be carried out since none were returned.Due to limited information about the damaged products, it is not possible to investigate this adverse even further.Without product samples and/or pictures the root cause of this incident could not be determined.
Event or Problem Description
The adverse event occurred outside us, in great britain.On (b)(6) 2026, a male patient contacted the manufacturer representative and reported that the primary package of the single-use intermittent urinary catheter lofric primo (40cm, ch14) was damaged.When the water sachet inside the primary package was squeezed, the water partially escaped through a hole in the primary package.Since the primary package is the sterile barrier of the product, a hole in the primary package is compromising the sterile barrier of the product.The patient reported that he had received three damaged products and that he had discarded these three products without using them.

• Brand Name: LOFRIC PRIMO
• Common Device Name: LOFRIC PRIMO NELATON MALE 40CM CH14
• 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: 24647485
• Report Number: 3009632672-2026-00010
• Device Sequence Number: 9760662
• Product Code: EZD
• UDI-Device Identifier: 07333387043012
• UDI-Public: 07333387043012
• 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): 03/20/2026

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: 41014
• Device Catalogue Number: 4101430
• Device Lot Number: 670418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• 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