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

Model Number	44314
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	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Used devices will not be returned to manufacturer for examination and batch documentation did not indicate any deviations on provided lot.Number.It is impossible for the manufacturer to confirm if the bleeding was due to a faulty product without any images or products to examine further, as the used devices were discarded.The patient appears to have a history of bph-related issues, but we (the manufacturer) do not have complete information on his co-morbidities and medications.The patient reports that his doctor did not properly introduce him to intermittent catheterization (ic).There is ample educational material available, and ic should always be taught by an experienced nurse.He states that "when he first began ic, his doctor gave him a handful of catheters and told him to wash and reuse them.He figured it out on his own with no proper teaching from his medical care team." lofric origo is intended for single use and should never be washed and reused, as clearly stated in the instructions for use (ifu).The patient also claims that he found a "burr" on the tip of the catheter, which caused bleeding and further complications related to the urolift procedure he underwent.It is evident that the patient did not receive proper introduction to ic or guidance on the most suitable catheter tip for him.Additionally, he has issues with an enlarged and easily bleeding prostate and is understandably shocked and upset by the bleeding and current situation.
Event or Problem Description
A 72-year-old man with an enlarged prostate had previously used the urolift system, a non-invasive treatment for bph that helps reduce prostate swelling and improve urine flow.He required intermittent catheterization (ic) alongside this procedure.On (b)(6) 2024, the patient informed the manufacturer that he had encountered "burs" at the tip of the catheters on two occasions.The first time he noticed a "bur," he discarded the catheter and used a new one.The second time, he did not notice the "bur" because it was nighttime.While catheterizing that night, he felt resistance and had a strong urge to urinate, so he "pushed harder," which caused bleeding.He went to the emergency room at the (b)(6) hospital and was admitted for 4 or 5 days.During his hospital stay, they performed a procedure to remove the urolift and stop the bleeding.He mentioned that he was "out of it" during his stay.The hospital advised him to stop using lofric catheters and provided alternative catheters.According to the patient, due to this incident and the damage caused by the catheter, he will now have to self-catheterize for the rest of his life.He also stated that his healthcare provider never provided self-catheterization training.When he first began cic, his doctor gave him a handful of catheters and told him to wash and reuse them.He figured it out on his own without proper instruction from his medical care team.

• Brand Name: LOFRIC ORIGO
• Common Device Name: LOFRIC ORIGO NELATON 40CM CH14
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer Contact: emad ramzi ; aminogatan 1; molndal, se-43121 molndal ; SW
• MDR Report Key: 20682238
• Report Number: 3009632672-2024-00020
• Device Sequence Number: 20971693
• Product Code: EZD
• UDI-Device Identifier: 07333387043333
• UDI-Public: 07333387043333
• 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): 11/14/2024

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 Expiration Date: 02/26/2024
• Device Model Number: 44314
• Device Catalogue Number: 4431440
• Device Lot Number: 654060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White