MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC ELLE; CATHETER STRAIGHT

Model Number	41814
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A young woman located in (b)(6), newly introduced to intermittent catheterization, used a single use, hydrophilic, ready to use urinary catheter (lofric elle).User had only the day before the incident been instructed by a healthcare professional on how to perform catheterization herself.User inserted the catheter into the urethra and emptied the bladder.When the user was going to remove the catheter from the urethra, the catheter could not be removed (pulled out).User tried several time to withdraw the catheter but with no success.An emergency doctor was contacted and arrived at the woman's home 45 minutes later.The emergency doctor removed the catheter by pushing the catheter back into the bladder before it was removed.The removed catheter was slightly wet with blood but had no damages.User was not hospitalized, and no further treatment was necessary.User experienced a burning pain in the urethra for 2 days before it returned normal.The emergency doctor had no explanation on why the catheter was "stuck" in the urethra but spoke of that a "suction" may have occurred.The user has an incomplete spinal cord injury and was unable to confirm the question if spasticity may have occured.The user is currently using a different brand of lofric catheters and is doing very well performing intermittent catheterization.
Additional Manufacturer Narrative
Batch documentation and production data for the affected lot have been reviewed and no relevant problems or deviations where registered.No earlier complaint have been registered for this lot.Three products from same package and lot as the affected catheter have been returned to manufacturer and analyzed.The investigation shows no defects or deviation.No sharp-edged holes on catheters could be found.The hydrophilic coating is somewhat thicker on the catheter tip but both that and the slipperiness of catheter is within specifications.High friction while inserting or withdrawing the catheter is correlated to increased risk of trauma and complications, and the slippery catheter surface is a pre-requisite to avoid this.Urethral trauma can cause pain and bleeding as well increased risk of urinary tract infections.Since lofric elle is a pre-wet catheter the user has not missed to activate the coating.Batch documentation and examination of returned devices has not shown any deviations.Therefore a root cause cannot be established.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 ELLE
• Common Device Name: CATHETER STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 1 21; SW SE-431 21
• Manufacturer Contact: ulrika skogback ; aminogatan 1; p.o.box 14; molndal, SE-43-1 21 ; SW SE-431 21
• MDR Report Key: 20675052
• Report Number: 3009632672-2024-00019
• Device Sequence Number: 8949262
• Product Code: EZD
• UDI-Device Identifier: 07333387024530
• UDI-Public: 07333387024530
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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: 05/02/2026
• Device Model Number: 41814
• Device Catalogue Number: 4181425
• Device Lot Number: 647634
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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 Age: 18 YR
• Patient Sex: Female