MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC ELLE; LOFRIC ELLE NELATON 10CM CH12

Model Number	41812
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Localized Skin Lesion (4542)
Date of Event	07/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A foreign incident occurred outside the united states.A 58-year-old female patient with a history of neurogenic bladder and interstitial cystitis reported experiencing trauma and bleeding following the use of a lofric elle intermittent urinary catheter.The catheter was inserted without difficulty; however, upon withdrawal, it was visibly covered in blood.The patient experienced significant pain and bleeding for approximately 4 to 5 hours, estimating the volume at ½ to 1 teaspoon per episode.The patient did not seek emergency medical care but contacted her general practitioner (gp), who advised monitoring the condition.Initially, the patient believed the catheter itself had caused a urethral injury.However, after reflecting on the situation, she reconsidered the cause of the trauma.She now believes it may not have been the catheter itself, but possibly a pre-existing blister, sore, or small lesion in or near the urethral area that was aggravated during catheterization.She suggested that when she inserted or removed the catheter, it may have rubbed against or irritated this already sensitive or damaged area, leading to the bleeding and pain she experienced.The patient discarded all used catheters and retained one visibly blood-contaminated unit, which was not returned due to contamination concerns.She continues to experience soreness and is using barrier cream while adjusting her catheterization technique.No relevant medications (e.G., blood thinners) were reported, and the patient has been using intermittent catheters since 2011.
Additional Manufacturer Narrative
Following receipt of the complaint, a preliminary investigation was conducted.The patient reported trauma and bleeding after using a lofric elle intermittent catheter.While the initial concern suggested a potential device-related injury, the patient later indicated that the trauma may have been caused by a pre-existing internal lesion or blister that was aggravated during catheterization.The used device was not returned to the manufacturer for evaluation due to contamination concerns.As a result, a physical inspection of the product could not be performed.However, a thorough review of the manufacturing batch records and quality control documentation associated with the product in question was completed.This review did not reveal any deviations, non-conformities, or anomalies that could have contributed to the reported event.Based on the available information, including the patient's medical history, the absence of returned product, and the clean batch documentation, there is no conclusive evidence to indicate a product defect or manufacturing issue.The incident appears to be isolated and potentially related to individual anatomical or medical factors rather than a systemic device failure.

• Brand Name: LOFRIC ELLE
• Common Device Name: LOFRIC ELLE NELATON 10CM CH12
• 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; p.o. box 14; mölndal, SE-43- 121 ; SW SE-43 121
• MDR Report Key: 22564518
• Report Number: 3009632672-2025-00021
• Device Sequence Number: 3904550
• Product Code: EZD
• UDI-Device Identifier: 07333387024202
• UDI-Public: 07333387024202
• Combination Product (Y/N): N
• PMA/510(K) Number: K211212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2025

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: 41812
• Device Catalogue Number: 4181225
• Device Lot Number: 664275
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/22/2025
• 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: Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White