MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB LOFRIC ORIGO; LOFRIC ORIGO TIEMANN CH14, 40CM

Model Number	44414
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Several attempts to get more information about the event has been made but without success and is has been judged impossible to get more information.Even though the used product was not available for return, and recalled products samples from same lot has not been possible to analyse it cannot be excluded the event was caused by the product quality problem behind the ongoing recall (z-2645-2020).
Event or Problem Description
According to the complaint, after use of the catheter there was a urethral bleeding, and the user went to the hospital.Information of the extent of bleeding, if only minor or more severe , or if patient was hospitalised or only visited a clinic for advice or treatment has not been possible to get information about although several attempts has been made to get information.This incident occurred in (b)(6).

• Brand Name: LOFRIC ORIGO
• Common Device Name: LOFRIC ORIGO TIEMANN CH14, 40CM
• 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: 10300538
• Report Number: 3009632672-2020-00007
• Device Sequence Number: 2576861
• Product Code: EZD
• UDI-Device Identifier: 07392532122576
• UDI-Public: 07392532122576
• 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: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

1 Device 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: 12/23/2021
• Device Model Number: 44414
• Device Catalogue Number: 4441465
• Device Lot Number: 447036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2645-2020