MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB LOFRIC ORIGO; CATHETER STRAIGHT

Model Number	44416
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the production batch records did not provide any conclusion for root cause.No earlier complaints registered for this 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
According to the patient, it was difficult to insert and to remove the urinary catheter, and he experienced a bleeding when the catheter was removed.The patient was unsure if the catheter was enough lubricated.The next day, the patient had an already scheduled appointment to a urology doctor, and at that time he experienced a minor bleeding.36 hours later, the patient experienced fever and went to the hospital, where he was diagnosed with a urinary tract infection (uti) and received antibiotics.The patient reported that he had a stent (placed in ureter/urethtra) removal two weeks before this incident, and he was then also treated for a uti.It was not established if the new uti was recurrent from the previous uti and the stent removal, or related to the incident.

• Brand Name: LOFRIC ORIGO
• Common Device Name: CATHETER STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; mölndal, SE-43 121; SW SE-43121
• MDR Report Key: 10634329
• Report Number: 3009632672-2020-00010
• Device Sequence Number: 11057472
• Product Code: EZD
• UDI-Device Identifier: 07392532122583
• UDI-Public: 07392532122583
• Combination Product (Y/N): N
• PMA/510(K) Number: K122078
• 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): 10/06/2020

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: 10/28/2021
• Device Model Number: 44416
• Device Catalogue Number: 44416
• Device Lot Number: 442691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR