MAUDE Adverse Event Report: WELLSPECT AB LOFRIC SENSE; LOFRIC SENSE NELATON 15CM FR14

Model Number	4161405
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not available to be returned.Without the benefit of examination and testing, wellspect healthcare is precluded from commenting on the condition of the device or the cause of the occurrence.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
On (b)(6) 2023 a female patient with sjogren's syndrome (autoimmune disorder), got an intermittent nelaton straight tip catheter (lofric sense fr14) stuck in her urethra during withdrawal.She had then to go to emergency care for removal.The catheter was removed in an er and a piece of mucosal tissue was stuck in an eyelet upon removal.The female patient had bleeding and a hematoma due to the injury.The patient caregiver (mother) noted the lofric sense solution felt thick and sticky.The er doctor believes diagnosis of sjogren's may be an influential factor as patients experience dryness in mucosal tissues.Within the week prior to their next er visit, patient urologist prescribed macrobid for a possible uti.The er provider prescribed an additional 10 days of antibiotics after removing the lofric sense catheter.The er advised to use additional gel lubricant with lofric sense going forward.The patient caregiver used this technique for the week following their er visit, didn't have any issues with lofric sense, and then received another catheter samples (cure catheters (inadvertently)), but they worked well for the patient.

• Brand Name: LOFRIC SENSE
• Common Device Name: LOFRIC SENSE NELATON 15CM FR14
• Manufacturer (Section D): WELLSPECT AB; aminogatan 1; p.o.box 14; molndal, SE-43 121,; SW SE-43121,
• Manufacturer (Section G): WELLSPECT AB; aminogatan 1; p.o.box14; molndal SE-43 121; SW SE-43121
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o.box14; molndal SE-43-121 ; SW SE-43121
• MDR Report Key: 17478853
• Report Number: 3009632672-2023-00002
• Device Sequence Number: 2647609
• Product Code: EZD
• UDI-Device Identifier: 07392532086489
• UDI-Public: 07392532086489
• Combination Product (Y/N): N
• PMA/510(K) Number: K123751
• 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): 08/08/2023

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: 02/05/2025
• Device Model Number: 4161405
• Device Catalogue Number: 4161405
• Device Lot Number: 639815
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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: Hospitalization
• Patient Age: 36 YR
• Patient Sex: Female