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

Model Number	44316
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned to the manufacturer for investigation.The review of the production and batch documentation of this lot number showed no deviations or previous complaints, indicating any deviations in the device quality.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 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 a bleeding during urinary catheterization, and therefore needed to seek medical care at the hospital.The patient stayed at hospital overnight, and he recovered well.The patient's partner reports that he might not has used the catheter properly.The incident occured in (b)(6).

• 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: 9171539
• Report Number: 3009632672-2019-00009
• Device Sequence Number: 2538091
• Product Code: EZD
• UDI-Device Identifier: 07392532122538
• UDI-Public: 07392532122538
• 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): 09/22/2019

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: 07/28/2021
• Device Model Number: 44316
• Device Catalogue Number: 44316
• Device Lot Number: 439417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2019
• Initial Report FDA Received Date: 10/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR