MAUDE Adverse Event Report: PRODUCTSO PARA EL CUIDADO DE LA SALUD URINARY 2 LITER DRAINAGE BAG

Catalog Number 154006

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

It was reported by the patient that starting in (b)(6) 2014, she has experienced an ongoing, severe urinary tract infection, testing positive for e.Coli and pneumococcal bacteria on (b)(6) 2014.The patient is concerned that this infection is related to the drain bags.She was hospitalized for this infection for two weeks due to this infection.The patient is catheterized due to a neurogenic bladder.She reports being allergic to many antibiotics, and also latex.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or willing to provide any further patient, product, or procedural details to bard.

• Brand Name: URINARY 2 LITER DRAINAGE BAG
• Manufacturer (Section D): PRODUCTSO PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km. 7 carretera internacional; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4687131
• MDR Text Key: 5710209
• Report Number: 1018233-2015-00111
• Device Sequence Number: 1
• Product Code: KNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 154006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention