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

Model Number	41012
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is on-going.The manufacturer is trying to get more information from the patient about this adverse event.The manufacturer has also asked for products to be returned.A follow-up report will be submitted when investigation is completed.
Event or Problem Description
The adverse event occurred outside us, in great britain.A patient reported on (b)(6) 2025, that several devices were received by the patient with broken primary packaging seal, compromising the sterile barrier of the device.The device is a sterile, single-use intermittent urinary catheter, lofric primo nelaton male 40cm ch12.Products with two different lot numbers were involved.Lot: 664407, manufacturing date: 17 january 2025, expiry date: 17 july 2028.Lot: 669391, manufacturing date: 13 june 2025, expiry date: 11 december 2028.It is unknown if the patient used any of the devices.No harm is reported.
Event or Problem Description
The adverse event occurred outside us, in great britain.A patient reported on (b)(6) 2025, that several devices were received by the patient with broken primary packaging seal, compromising the sterile barrier of the device.The device is a sterile, single-use intermittent urinary catheter, lofric primo nelaton male 40cm ch12.Products with two different lot numbers were involved.Lot: 664407, manufacturing date: 17 january 2025, expiry date: 17 july 2028, lot: 669391, manufacturing date: 13 june 2025, expiry date: 11 december 2028, it is unknown if the patient used any of the devices.No harm is reported.
Additional Manufacturer Narrative
Batch documentation and production data have been reviewed for both lot numbers, and no relevant problems or deviations were registered.No earlier complaints are registered for either of the two lot numbers.The only information provided by the patient is that several devices were received by the patient with broken primary packaging seal, compromising the sterile barrier of the device.Described in this way by the patient "blue plastic seal is broken leaving the catheters loose in the box poking out at the end." it is unknown if the patient used any of the devices.No harm is reported.The manufacturer has tried multiple times to get more information from the patient about this adverse event, but the patient is unresponsive.The manufacturer has also asked for products to be returned but no products have been returned.Since no products samples were available, examination could not be carried out.And the root cause of this adverse event could not to established.

• Brand Name: LOFRIC PRIMO
• 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: 23355811
• Report Number: 3009632672-2025-00036
• Device Sequence Number: 8899948
• Product Code: EZD
• UDI-Device Identifier: 07333387043005
• UDI-Public: 07333387043005
• 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,Followup
• Report Date (Section B): 11/17/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 41012
• Device Catalogue Number: 4101225
• Device Lot Number: 664407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2025
• 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: Unknown