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

Model Number	40512
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not available to be returned.Without the benefit of examination and testing , wellspect healthcare is precluded from commenting on the condition of the device or the cause of the occurence.Should the device or additional information be received, a follow up report will be filed.
Event or Problem Description
The reporter believed that a particle on the catheter surface caused him an injury resulting in an infection.The patient was treated successfully with antibiotics and has recovered.

• Brand Name: LOFRIC
• Common Device Name: CATHETER, URETHRAL
• 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: 9260447
• Report Number: 3009632672-2019-00010
• Device Sequence Number: 1879617
• Product Code: EZD
• UDI-Device Identifier: 07392532131745
• UDI-Public: 07392532131745
• Combination Product (Y/N): N
• PMA/510(K) Number: K896750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/06/2022
• Device Model Number: 40512
• Device Catalogue Number: 40512
• Device Lot Number: 18190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/31/2019
• 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: 48 YR
• Patient Weight: 99