MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ INTERMITTENT CATHETER; MAGIC 3 ANTIBACTERIAL HYDROPHILIC INTERMITTENT CATHETER

Model Number	51914
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the patient experienced an urinary tract infection after using the magic 3 catheter.The patient was treated with antibiotics.She had decided to resume using the cure catheter.
Event or Problem Description
It was reported that the patient experienced an urinary tract infection after using the magic 3 catheter.The patient was treated with antibiotics.She had decided to resume using the cure catheter.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "intended use the catheter is intended for urinary bladder drainage in adult males and females requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.Efficacy of the catheter in preventing urinary tract infection during intermittent use has not been established.The device is not intended to be used as a treatment for active urinary tract infection.Please contact your physician to determine which product options are best for you, paying close attention to product warnings/ precautions and adverse reactions." the device was not returned.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER
• Common Device Name: MAGIC 3 ANTIBACTERIAL HYDROPHILIC INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8424092
• Report Number: 1018233-2019-01322
• Device Sequence Number: 2051321
• Product Code: MJC
• UDI-Device Identifier: 00801741068294
• UDI-Public: (01)00801741068294
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K001143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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 Model Number: 51914
• Device Catalogue Number: 51914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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: Required Intervention