MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC; LOFRIC ORIGO

Model Number	44314
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Genital Bleeding (4507)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A male patient reported bleeding for several days after using intermittent urinary catheter (lofric origo).He is an experienced user and has used lofric origo during several years.Starting around (b)(6) 2024 patient have had a few bouts of bleeding probably due to rough edges around the catheter hole according to the patient himself.The last bout of bleeding lasted over four days.The patient also claims that the coating of the catheter is not a "slippery" as it has been in the past.Urinalysis and urine cultures has been performed, ordered by patient's urologist.Both were negative.Last bleeding, which was moderate, lasted for 4 days.At that time, patient visited his urologist's office and urinalysis and an urine culture was performed.Both were negative and no obstructions was detected in urethra.After exaimination the patient was given new catheter samples of a different brand to try.
Additional Manufacturer Narrative
The batch documentation for the affected device has been reviewed and no deviations was found.The returned product samples of the same lot were examined and showed no defects or deviations.Investigation of the batch documentation and the returned product samples did not provide conclusion for root cause.Manufacturer concludes that this is an isolated event.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 ORIGO
• 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: ulrika skogback ; aminogatan 1; p.o.box 14; molndal SE-43-121 ; SW SE-43121
• MDR Report Key: 19631439
• Report Number: 3009632672-2024-00007
• Device Sequence Number: 8563300
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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
• Device Expiration Date: 12/05/2025
• Device Model Number: 44314
• Device Catalogue Number: 4431440
• Device Lot Number: 651003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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 Sex: Male