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

Model Number	44416
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch documentation and production data have been reviewed, and no deviations or earlier complaints have been registered for the lot.No device was returned to the manufacturer, so it was not possible to include the device used in the investigation.The cause of this adverse event has not been possible to establish.Should additional facts prompt us to alter or supplement any information of conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
This adverse event occurred in the usa.A male patient with the medical condition urinary retention, bph, constipation and diabetes, has been using a sterile, single-use, intermittent urinary catheter, lofric origo coudé (16'' 16fr).On (b)(6) 2025, the patient informed the manufacturer representative that he had an incident with the catheter 2 days ago.The patient, who is new to the therapy intermittent catheterization, had problems inserting the catheter and he experienced it very resistant to insert.He stated he did experience pain when he met the resistance.After he had removed the catheter, severe bleeding occurred (probably a fruit juice glass size of blood, according to the patient).The patient went to the hospital emergency due to the bleeding.He stated that the hospital placed a foley catheter and told him that his prostate was swollen and "pinched off the urethra." he was then released home.The only treatment he had was a foley catheter inserted.He stated he will have the foley until on (b)(6) as that's the soonest the urologist could see him.The manufacturer representative provided education for ic technique, ways to relax the sphincter and ease the catheter in, coude tip and indicator ridge use, and advised to never force the catheters in if/when he resumes cic.

• Brand Name: LOFRIC ORIGO
• 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-43 121
• MDR Report Key: 23776510
• Report Number: 3009632672-2025-00042
• Device Sequence Number: 9933824
• Product Code: EZD
• UDI-Device Identifier: 07333387043456
• UDI-Public: 07333387043456
• Combination Product (Y/N): N
• PMA/510(K) Number: K250659
• 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): 12/11/2025

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
• Device Lot Number: 669839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• 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: Male