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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Erosion (1750); Erythema (1840); Fever (1858); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Irritation (1941); Pain (1994); Scarring (2061); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Discharge (2225); Urinary Frequency (2275); Discomfort (2330); Depression (2361); Fungal Infection (2419); Hematuria (2558); Blood Loss (2597); Dysuria (2684)

Event Type  Injury  

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 precautions: "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." sample not received.

Event 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 irritation from catheter, vaginal discharge, vaginal pain, chronic granulation tissue in vagina, persistent vaginal irritation, persistent vaginal bleeding, bacterial vaginosis, vaginitis, erythema, chronic low back pain, abdominal pain, mild left lower quadrant discomfort, chronic pelvic pain, suprapubic discomfort, left groin pain and drainage, occult erosion with persistent pain and irritation, pelvic abscess with right groin, tenderness over bladder neck, urinary mixed incontinence, stress urinary incontinence, leakage, urinary frequency, urinary retention, voiding dysfunction, extrinsic sphincter deficiency status-post anterior vaginal wall reconstruction, microhematuria, pyuria, dysuria, trace bacteruria, vaginitis yeast infection, postoperative infection, intermittent fevers, febrile urinary tract infection (pseudomonas), intermittent hematuria, lower urinary tract problems, drainage of bloody fluid, mild bloody drainage from previous drain site, intermittent bleeding from previous groin exploration, draining sinus in intra-abdominal wall, pelvic hematoma, hypermobility of urethra, thickening and change in left lower quadrant area, postsurgical changes at bladder neck, heterotopic ossification related to surgery, ill-defined stranding, soft tissue fullness within subcutaneous fat overlying low left pelvis, changes in left hemipelvis, hyperplastic tissue, granulation tissue in urethra very thin, involved bladder neck, collection of pelvilace material in suprapubic area, small capsular area in suprapubic area, exposed mesh on right side near bladder neck, unspecified extrusion, unspecified bowel problems, unspecified recurrence, dyspareunia, vaginal scarring, back aches, depression, vaginal and bladder infections, inability to hold bladder, painful intercourse, left groin abscess, closure of anterior wall, residual graft material with removal and sling redo and required multiple surgical interventions.

• Type of Device: PELVILACE BIOURETHRAL SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8697074
• MDR Text Key: 148005588
• Report Number: 1018233-2019-03121
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2006
• 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