MAUDE Adverse Event Report: WELLSPECT HELATHCARE LOFRIC ORIGO; LOFRIC ORIGO FR16 TIMEANN

Model Number	44416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A male patient used a lofric origo intermittent catheter fr16 with coude tip on (b)(6) 2023.The patient felt a "snag" and had some difficulty with insertion.The following day ( (b)(6)2023) he had a large amount of blood and blood clots in his urine.This continued a few days.On day 3 he went to his care clinic, but his urine was cleared up by then.One ( (b)(6) 2023) he saw a small amount of blood again, so he called the care clinic for examination.His doctor couldn't say if his bleeding was related to his catheter use or not.This patient does have a hydrocele and hernia and will have surgery in (b)(6) 2023.This is unrelated to catheter use.Furthermore, the patient has history of enlarge prostate, heart disease and take a blood thinner medicine.
Additional Manufacturer Narrative
Bleeding is one of the lower urinary tract symptoms seen in patients with benign prostatic hyperplasia.The patient was diagnosed with bph which can cause uncomfortable urinary symptoms, such as blocking the flow of urine out of the bladder.It can also cause bladder, urinary tract or kidney problems and sign of blood in urine which is well known by both the patients and health care professionals.In this case, the patient was diagnosed with benign prostatic hyperplasia, and this may have contributed to the bleeding.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.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 ORIGO
• Common Device Name: LOFRIC ORIGO FR16 TIMEANN
• Manufacturer (Section D): WELLSPECT HELATHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer (Section G): WELLSPECT HELATHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o.box14; molndal, SE-43-151 ; SW SE-43151
• MDR Report Key: 16407270
• Report Number: 3009632672-2023-00001
• Device Sequence Number: 12282526
• Product Code: EZD
• UDI-Device Identifier: 07392532122583
• UDI-Public: 07392532122583
• 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
• Report Date (Section B): 02/21/2023

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: 44416
• Device Catalogue Number: 4441640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Sex: Male