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

Model Number	44310
Medical Device Problem Codes	Product Quality Problem (1506); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the production batch records did not provide conclusion for root cause.No earlier complaint registered for this lot.Should additional fact prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
Event occured in united kingdom, i.E.Outside usa.The patient had been performing intermittent self catheterization (isc) for 2.5 years without any problem.At one occasion, while inserting the catheter tube in to the urethra, he noticed a notch on the upper half of the catheter tube, about 6.5 cm from the funnel.He stopped inserting the catheter and withdrew it instead, before the notch entered the urethra.No injury reported.The patient used the other products in the box, and they had no defects.

• Brand Name: LOFRIC ORIGO
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; mölndal, 43121 ; SW 43121
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; mölndal, 43121 ; SW 43121
• Manufacturer Contact: ms lundqvist ; aminogatan 1; p.o. box 14; mölndal, 43121 ; SW 43121
• MDR Report Key: 19179412
• Report Number: 3009632672-2024-00003
• Device Sequence Number: 7147374
• Product Code: EZD
• UDI-Device Identifier: 07333387043296
• UDI-Public: 07333387043296
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Expiration Date: 07/06/2025
• Device Model Number: 44310
• Device Catalogue Number: 4431025
• Device Lot Number: 645745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• 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 Age: 75 YR
• Patient Sex: Male