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

Model Number	41512
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device is discarded.The manufactured has asked for unused samples from the same lot number to be returned for evaluation, but no samples have been returned.The review of the batch records for the affected lot number showed no deviation that can explain the incident.Without the benefit of examination and testing the device, the manufacturer 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 the original mdr report, a follow-up report will be submitted.
Event or Problem Description
The event occurred in (b)(6), i.E.Outside usa.According to complaint report the patient injured the urethra and experienced a minor bleeding during the catheterization procedure.The patient, who is said to be an experienced user of urinary catheters had described that there was a small plastic part on the tip of the catheter which got stuck in the urethra.The patient had said he removed the small plastic part by "pushing and pulling on it", by himself.A minor bleeding was noticed and the patient met a doctor and was given an indwelling catheter while healing.The following day the patient was discharged, and in good health.

• 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: 10090929
• Report Number: 3009632672-2020-00005
• Device Sequence Number: 19684771
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/28/2023
• Device Model Number: 41512
• Device Catalogue Number: 41512
• Device Lot Number: 445572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/27/2020
• 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: Hospitalization; Other