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

Model Number	41512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Urinary catheterization therapy is associated with an increased risk of urethral bleeding, which normally is mild and transient without medical intervention.In patients treated with anticoagulants (ac) the risk of prolonged bleeding is increased, which is well known by both the patients and health care professionals.In this case, the patient was on ac treatment, and this may have contributed to the bleeding.It has not been possible to investigate any products, as no products of the actual lot have been returned to the manufacturer.The review of the production batch records did not show any relevant deviations or complaints registered for this lot.Without the benefit of examination and testing, (b)(6) 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
The patient received another model of urinary catheter than he was prescribed (patient received a 40 cm catheter size 12fr coude tip, instead of the prescribed 40 cm catheter size 16fr straight tip), due to a mistake when the products were delivered from the warehouse.The labelling information for the delivered products was correct.The patient noticed that the package was different, but used the delivered products anyway and experienced a bleeding during the urinary catheterization procedure.The day after, the patient had an already scheduled appointment at the doctor, and at that time there was no bleeding.The next day the bleeding resumed, and the patient revisited the doctor.The patient received a foley catheter to have in place for at least two weeks.No other medical complications are reported, no hospitalization was needed.The patient takes anticoagulant treatment.The overall condition for the patient was well.

• Brand Name: LOFRIC PRIMO
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; moelndal, SE-43 121; SW SE-43121
• MDR Report Key: 10703665
• Report Number: 3009632672-2020-00012
• Device Sequence Number: 19580383
• Product Code: EZD
• UDI-Device Identifier: 07392532131615
• UDI-Public: 07392532131615
• 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): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

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: 06/01/2022
• Device Model Number: 41512
• Device Catalogue Number: 41512
• Device Lot Number: 429335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/20/2020
• 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: 64 YR