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

Catalog Number UNKNOWN

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 lot number is unknown; therefore, the device history record could not be reviewed.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: ¿complications associated with the proper implantation of the avaulta plus¿ biosynthetic support system may include, but are not limited to those typically associated with surgically implantable materials, including: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding and defecatory dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, rectum, or any viscera, which may occur during the implantation procedure.Irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.Extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.Inflammation, sensitization, rejection of biologic materials, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of vaginal wall prolapse.Urinary incontinence (stress and urge)." 1994="l" 2348, 2993, 2371= "nl" 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.No sample received.

Event Description

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 SUPPORT SYSTEM
• Type of Device: AVAULTA 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: 11207945
• MDR Text Key: 227993551
• Report Number: 1018233-2021-80005
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/13/2021
• 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
• Treatment: BARD AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 93