MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC PRIMO; LOFRIC PRIMO NELATON 40 CM FR14

Model Number 41014

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/22/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has evaluated the returned devices and the device record.As no defect has been identified on the device the 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.

Event Description

The incident concern usage of lofric primo intermittent urinary catheter which occurred in france.Patient claimed that he has been using lofric primo catheter 40 cm nelaton (straight tip), fr 14 which has caused bleeding and irritation.After incident patient consulted the emergency department because of pain.He was treated with spasfon and paracetamol.No antibiotic was prescribed.During the medication treatment the patient's catheters was replaced by an indwelling (foley) catheter with an external collecting urinary bag.After june 22 it has been confirmed that the patient has been recommended again to use intermittent catheter.

• Brand Name: LOFRIC PRIMO
• Type of Device: LOFRIC PRIMO NELATON 40 CM FR14
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; po box 14; mölndal, SE-43 121; SW SE-43121
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; po box 14; mölndal, SE-43 1 21; SW SE-431 21
• Manufacturer Contact: ulrika skogbäck ; aminogata 1; po box 14; mölndal, SE-43-1 21 ; SW SE-431 21
• MDR Report Key: 15223151
• MDR Text Key: 298200762
• Report Number: 3009632672-2022-00003
• Device Sequence Number: 1
• Product Code: EZD
• Combination Product (y/n): N
• PMA/PMN Number: K122078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 41014
• Device Catalogue Number: 4101440
• Device Lot Number: 486867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male