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

Catalog Number 482150

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

Patient Problems Abdominal Pain (1685); Anemia (1706); Erosion (1750); Fatigue (1849); Micturition Urgency (1871); Incontinence (1928); Ischemia (1942); Itching Sensation (1943); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Pressure Sores (2326); Discomfort (2330); Weight Changes (2607); Intermenstrual Bleeding (2665); Constipation (3274); Dyspareunia (4505); Alteration in Body Temperature (4568); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced pain, discomfort, urinary problems, and dyspareunia.Patient has required additional surgical interventions.Product was used for therapeutic treatment.It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, erosion and urinary incontinence.Product was used for therapeutic treatment.Per additional litigation on february 22, 2019, patient has experienced pain, dyspareunia, discomfort, urinary problems and additional surgical intervention.Per additional information received on 12nov2021, the patient has experienced anemia, tobacco use disorder, mesh complications, pain during sexual intercourse, pelvic myofascial pain, vaginal bulge, pelvic pressure symptoms, urinary leakage, urge incontinence, urinary urgency, urinary frequency, incomplete emptying the bladder, urinary tract infections, bowel symptoms, chronic constipation, hematochezia attributed to ischemic colitis, dyspareunia, weight loss, chronic back pain, palpable area of left urethra on the anterior vaginal wall, mixed urinary incontinence, fatigue, nausea, dark vaginal discharge, bleeding, abdominal pain, difficulty in micturition, loss of appetite, vaginal wound separation, low grade temperature, foul odor, urinary burning sensation, vaginal itching, sores in mouth and required additional surgical and non-surgical interventions.

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation and the lot number is unknown.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue.The alleged event is most likely associated with possible procedural/surgical complications.The ifu currently addresses potential risks associated with surgically implantable materials which states the following: 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.Potential complications: complications associated with the proper implantation of the pelvilace¿ biourethral support system may include, but are not limited to: postoperative hematoma.Temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder or bowel, which may occur during needle passage.(b)(4).

• Brand Name: PELVILACE® BIOURETHRAL SUPPORT SYSTEM
• 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: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 12845047
• MDR Text Key: 281026509
• Report Number: 1018233-2021-80093
• 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: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 482150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/12/2021
• 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
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Race: White