MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC HYDRO-KIT; LOFRIC HYDRO-KIT NELATON 40CM CH14

Model Number	42014
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch documentation was reviewed, and no deviations related to this issue were found.A total of twelve (12) unused products were returned for evaluation.Examination of these samples revealed that one product had a small hole in the urine bag.The defect is located along the fold line of the products, specifically in the area where the water sachet is inserted into the urinary bag.Our assessment indicates that there are two plausible areas within the production line where this type of damage could potentially occur.However, due to limited number of defective samples available for analysis, it is not possible to determine the definite root cause.No medical complications were reported by the patient.The only noted impact was discomfort associated with the leaking product.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
Adverse event occurred outside us, in france, where a patient reported having found defective micro-perforated catheters that leaked during use.This observation indicates a potential compromise of the product's sterile barrier.A total of 12 products were returned to the manufacturer for evaluation.At the time of the event, the patient already had a diagnosed urinary tract infection (uti) and received intramuscular antibiotic treatment.The patient also has underlying medical conditions, including urinary calculi and fournier's gangrene.A surgical intervention involving the ureter and the right kidney is schedules for 17 february already before this incident.According to the patient, the uti is not considered related to the use of the lofric hydro-kit catheter but is attributed to the presence of urinary stones.No harm or medical complications are reported related to this incident.Lofric hydro-kit is a sterile single use urinary catheter.Each primary package consists of a catheter, a water sachet (wetting solution bag) and a urine collection bag.The wetting solution bag is used to activate the hydrophilic catheter coating before use.

• Brand Name: LOFRIC HYDRO-KIT
• Common Device Name: LOFRIC HYDRO-KIT NELATON 40CM CH14
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; mölndal, SE-43 1 21; SW SE-431 21
• Manufacturer Contact: ulrika skogbäck ; aminogatan 1; p.o.box 14; mölndal, SE-43-1 21 ; SW SE-431 21
• MDR Report Key: 24386865
• Report Number: 3009632672-2026-00003
• Device Sequence Number: 10278946
• Product Code: EZD
• UDI-Device Identifier: 07333387042824
• UDI-Public: 07333387042824
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 42014
• Device Catalogue Number: 42014703
• Device Lot Number: 674885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (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: Unknown