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

Model Number	44312
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
The actual device was not returned for examination, but unused devices from the same lot number were returned to the manufacturer.Examination of the unused returned devices, and review of the batch documentation showed no deviations, and no root cause could be established.Should the device or additional information be received, a follow up report will be filed.
Event or Problem Description
According to the reporter, the patient experienced pain when performing urinary catheterisation.After a few days the patient experienced a bleeding when performing urinary catheterisation and went to hospital.The patient was hospitalized for one day.The bleeding did not reoccur, and there were no other medical complications to the patient.

• 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; moelndal, SE-43 121; SW SE-43121
• MDR Report Key: 9278274
• Report Number: 3009632672-2019-00011
• Device Sequence Number: 11359852
• Product Code: EZD
• UDI-Device Identifier: 07392532158292
• UDI-Public: 07392532158292
• Combination Product (Y/N): N
• PMA/510(K) Number: K122078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2019

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: 11/28/2020
• Device Model Number: 44312
• Device Catalogue Number: 44312
• Device Lot Number: 427842
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/05/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR