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

Catalog Number UNKNOWN

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

Patient Problems Pain (1994); Discharge (2225); 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)." (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, suffering, disability and impairment.Per additional information received, the patient has experienced erythematous incision, buttocks discharge, vaginal tenderness, bilateral sterile abscesses, e-coli infection, infected sinus tract, pelvic abscess, vaginal scarring, proctoscopy, exam under anesthesia, exploration of abscess in the ischiorectal fossa, incision and drainage of the ischiorectal fossa abscess bilaterally and excision of infected sinus tract, incision and drainage of rectovaginal abscess with removal of mesh, posterior colpoperineorrhaphy, interpulse high flow suction irrigation of the ischiorectal abscesses using the stryker interpulse system, placement of penrose drains, abscess infections with gram-positive cocci, gamma hemolytic streptococcus and diphtheroids, mesh excision pathology with fibrosis, acute and chronic inflammation and granulation, home health for wound care x 3 months, yeast infection, stress, abdominal pain, grade two to three cystocele, acute stress, chronic constipation, dyspareunia, fecal incontinence, enlarged spleen, anemia, depression, anxiety, adhesions, blood loss, pelvic/rectrovaginal/ischiorectal fossa abscess (abscess), sinus tracking, gram-positive cocci, gamma hemolytic streptococcus, diphtheroids, pelvic fullness/tenderness, discomfort, infected mesh (infection), scar (scarring), palpable mesh, mesh indenting rectal mucosa, hemorrhoids, embedded mesh, large cavity with purulent material, sinus scar, rectocele (prolapse), and required nonsurgical, additional surgical interventions, vaginal tenderness, inflammation of vaginal cuff, loose stools, bilateral sterile abscess of buttocks with drainage of clear serous fluid, painful scar on bilateral vaginal walls, bilateral ischiorectal fossa abscess, perirectal and perivaginal abscess connecting to buttock sinus, rectovaginal abscess, examination under anesthesia, proctoscopy, exploration of abscess in the ischiorectal fossa, incision and drainage of ischiorectal fossa bilaterally and excision of infected sinus tract, incision and drainage of rectovaginal abscess with removal of mesh, posterior colpoperineorrhaphy, and interpulse high flow suction irrigation of the ischiorectal abscesses, hemorrhoid, rectocele, lower abdominal pain, vaginal yeast infection, suprapubic pain, cystocele, chronic constipation, diarrhea, pain with bowel movement, rectal urgency, hematuria, dysuria, abdominal adhesions, urethrocele, recurrent urinary tract infections, vaginal cyst biopsy, dyspareunia, apareunia, scar of posterior vaginal wall, atrophic vaginitis, fecal incontinence, kinked urethra, incomplete bladder emptying, urinary frequency, urgency, cystocele and anterior enterocele repair augmented with dermapure graft, vault suspension to ischial spine, and excision of vaginal cyst on the anterior vaginal wall, multiple nonsurgical, surgical procedures, numerous home health skilled nursing visits, generalized hives and urticaria.

• Brand Name: AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
• Type of Device: AVAULTA PLUS BIOSYNTHETIC 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: 9770163
• MDR Text Key: 187846846
• Report Number: 1018233-2020-01432
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• 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: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 57 YR
• Patient Weight: 112