MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233; PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE

Device Problem Material Erosion (1214)

Patient Problems Anemia (1706); Dehydration (1807); Ecchymosis (1818)

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 adverse events: "potential complications associated with the proper implantation of the pelvilace to system may include, but are not limited to postoperative hematoma, which may occur following the implant procedure.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 transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion at the implant site".(b)(4).The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Sample not received.

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced blood loss, vaginal mesh and left anterior graft erosion, dyspareunia, pain with palpation of anterior and posterior apical arms, tenderness posteriorly near the introitus at palpation of the mesh, granulation tissue, pelvic pain, left posterior graft constriction and constriction band, urinary tract infection, methicillin resistant staphylococcus aureus (bacterial infection), pyelonephritis, back pain, graft had grown into the surrounding tissue and became very fibrotic (fibrosis, foreign body in patient), failed graft (failure of implant), extrusion, unspecified urinary problems, unspecified bowel problems, unspecified neuromuscular problems, vaginal scarring, abdominal pain, painful intercourse, vaginal bleeding, scar tissue, recurrence, stress urinary incontinence, migration, mild ecchymosis on bilateral gluteal regions, anemia, dehydration, persistent headache, reflux symptoms, inability to void, foley replacement, urinary retention, neurogenic pain, buttocks pain, vaginal pain, hematuria, urgency, low back pain, right leg pain, cystitis and pyelonephritis, back problems and tenderness, mild diffuse bladder wall thickening, graft erosion, revision of anterior graft, revision of posterior graft, methicillin resistant staph-aureus vaginal infection, discomfort in the vaginal area, placement of peripherally inserted central catheter, dyspareunia, vaginal mesh erosion with revision of transvaginal mesh, multiple non surgical and surgical interventions.

• Type of Device: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
• 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: 8691580
• MDR Text Key: 147858280
• Report Number: 1018233-2019-03043
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• 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: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2007
• 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 Weight: 94