MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC; LOFRIC NELATON 20 CM FR14

Model Number	40314
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The incident concern usage of lofric nelaton intermittent urinary catheter which occurred in austria.Patient claimed that she had used lofric 20 cm catheter nelaton (straight tip) fr 14 and experienced that the catheter tip was catheter tip was rough and was consequently injured.The patient consulted medical care because of soreness and bleeding.No further information has been received.
Additional Manufacturer Narrative
The product was not available to be returned.Without the benefit of examination and testing, wellspect healthcare is precluded from commenting on the condition of the device or the cause of the occurrence.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
• Common Device Name: LOFRIC NELATON 20 CM FR14
• 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, SE-43 121; SW SE-43121
• Manufacturer Contact: ulrika skogbäck ; aminogatan 1; p.o.box 14; mölndal, SE-43-121 ; SW SE-43121
• MDR Report Key: 15257615
• Report Number: 3009632672-2022-00004
• Device Sequence Number: 12233994
• Product Code: EZD
• UDI-Device Identifier: 07392532135132
• UDI-Public: 07392532135132
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 40314
• Device Catalogue Number: 4031440
• Device Lot Number: 621673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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: Female