MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR; AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

Catalog Number 486201

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

Patient Problems Pain (1994); Injury (2348); Disability (2371)

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: hematoma, seroma, mucosal or visceral erosion, infection, inflammation, sensitization, dyspareunia, scarification and contraction, fistula formation, extrusion and recurrence of vaginal wall prolapse.Perforations or lacerations of vessels, nerves, bladder, bowel, rectum, or any viscera may occur during needle passage.(b)(4).

Event Description

It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, injury, disability, and impairment.Per additional information received, the patient has experienced unspecified complication of genitourinary prosthetic device, implant and graft, sequela, pelvic and perineal pain, unspecified dyspareunia, mixed incontinence, vesicovaginal fistula, hematuria unspecified, peritoneal adhesions, postmenopausal atrophic vaginitis, crossing vessel and stricture of ureter without hydronephrosis, vaginal pain, tightness and discomfort, hysterectomy with oophorectomy, swollen, pain in pelvis and pain with urination, mesh erosion, urinary urgency, pelvic organ prolapse, hard to empty her bladder, cystocele, pelvic pain, "rubber bands" in her vagina and pelvis, strong urge to urinate occasionally, urinary incontinence, lack of desire for intercourse, urinary tract infection, vaginal atrophy, tenderness along lateral palpable trans-obturator arms of the mesh, scar tissue, mesh contracted, recurrent prolapse, inflammation, mixed incontinence, female dyspareunia, pelvic pain, unspecified complication of genitourinary prosthetic device, implant and graft, sequela, small fistula, intra-detrusor hematoma, vesicovaginal fistula, fever, abdominal pain, vaginal discharge, diverticulitis suspected.The patient required additional surgical and non-surgical interventions.

• Brand Name: AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Type of Device: AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR
• 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: 11162719
• MDR Text Key: 227101050
• Report Number: 1018233-2021-80001
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082571
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2011
• Device Catalogue Number: 486201
• Device Lot Number: BMUC0018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2010
• 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: 45 YR
• Patient Weight: 93