MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233; PELVILACE® BIOURETHRAL SUPPORT SYSTEM

Health Effect - Clinical Codes	Abdominal Pain (1685); Erosion (1750); Cyst(s) (1800); Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Incontinence (1928); Inflammation (1932); Pain (1994); Perforation (2001); Urinary Tract Infection (2120); Weakness (2145); Dizziness (2194); Prolapse (2475); Hematuria (2558); Constipation (3274)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: "the pelvilace¿ biourethral support system is for single-patient use only and is to be implanted surgically.Do not use the pelvilace¿ biourethral support system if the integrity of the packaging appears compromised.The pelvilace¿ biourethral support system pelvicol® implant should be hydrated or moist when the package is opened.Dehydrated or dry tissue should not be implanted.Postoperative retropubic bleeding may occur in some patients and must be controlled prior to patient release.The pelvilace¿ biourethral support system procedure requires diligent attention to anatomical structure and care to avoid puncture of large vessels, nerves, bladder, and bowel, during needle passage.Proper placement of the pelvilace¿ biourethral support system at mid-urethra requires that the tissue lie flat with minimal or no tension under the urethra.The pelvilace¿ biourethral support system is intended as a single-use, disposable device.Do not resterilize any portion of the pelvilace¿ biourethral support system.Patients should be advised that pregnancy following an pelvilace¿ biourethral support system procedure may negatively affect the success of the previous procedure and incontinence may reoccur.The safety and effectiveness of pelvilace¿ biourethral support system has not been established for the treatment of stress urinary incontinence in males and children under the age of 18.¿.
Event or Problem Description
The patient's attorney alleged a deficiency against the device.It was reported by the patient¿s attorney that as a result of having the product implanted, the patient has experienced hemorrhoids, constipation, urinary tract infection, cystitis (inflammation), urinary incontinence, blood, nitrates, many bacteria, leukocytes, white blood cells, red blood cells in urine (hematuria and bacterial infection), abdominal pain, anemia, low red blood cells, hemoglobin and hematocrit, high eosinophils, escherichia coli in urine, rectal bleed secondary to internal hemorrhoids (blood loss), dizziness, difficulty with bowel movement, blood while straining, weakness, constipation and moderate fecal retention, tiny calculus mid pole of the left kidney, lower pole of right kidney, small left renal cyst, low potassium (electrolyte imbalance), retention, enterocele, colovesical fistula, recurrence, pain, unspecified urinary problems, unspecified neuromuscular problems, organ perforation, pelvic pain, erosion, vaginal bleeding, unspecified bowel problems, unspecified perforation, recurrence, pelvic organ prolapse, stress migration and extrusion, cystocele, foreign body in patient, urethra disorder, female genital prolapse, additional surgical and nonsurgical intervention.

• Common Device Name: PELVILACE® BIOURETHRAL SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8680472
• Report Number: 1018233-2019-02982
• Device Sequence Number: 2120479
• Product Code: PAG
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/07/2019
• 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