MAUDE Adverse Event Report: WELLSPECT HEALTHCARE(A DIVISION OF DENTSPLY IH AB) LOFRIC; LOFRIC NELATON 16 INCH, FR18

Model Number	40018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Urinary Tract Infection (2120)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient could not provide the device lot.No products of the actual batch have been returned to the manufacturer for investigation.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
Customer reported moderate bleeding from catheter usage and to request a different french size.Our clinical nurse, reached out to the patient and learned he wasn't activating lofric classic (dry catheter) properly.He was using a gel lubricant and not soaking for 30 seconds with water according to provided instructions for use.He was also using 18fr samples he had leftover at home.His regular shipment is for 16fr.He said he prefers using a lofric catheter with lubricant (saline solution).Wellspect customer service emailed the patient product catalog, ifus, men's guide and instructional videos to help him figure it out.The patient was encouraged to contact customer service if he had any question about product usage.

• Brand Name: LOFRIC
• Common Device Name: LOFRIC NELATON 16 INCH, FR18
• Manufacturer (Section D): WELLSPECT HEALTHCARE(A DIVISION OF DENTSPLY IH AB); aminogatan 1; p.o box 14; mölndal, SE-43 1 21; SW SE-431 21
• Manufacturer (Section G): WELLSPECT HEALTHCARE(A DIVISION OF DENTSPLY IH AB); aminogatan 1; p.o.box 14; mölndal, SE-43 1 21; SW SE-431 21
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o. box 14; mölndal, SE 43-1 21 ; SW SE 431 21
• MDR Report Key: 14268178
• Report Number: 3009632567-2022-00001
• Device Sequence Number: 4438781
• Product Code: EZD
• UDI-Device Identifier: 07392532131813
• UDI-Public: 07392532131813
• Combination Product (Y/N): N
• PMA/510(K) Number: K113424
• 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): 04/15/2022

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: 40018
• Device Catalogue Number: 4001840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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