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

Catalog Number 486101

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Bronchitis (1752); Chest Pain (1776); Fatigue (1849); Foreign Body Sensation in Eye (1869); Micturition Urgency (1871); Headache (1880); Failure of Implant (1924); Incontinence (1928); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Hernia (2240); Urinary Frequency (2275); Anxiety (2328); Distress (2329); Discomfort (2330); Injury (2348); Sore Throat (2396); Prolapse (2475); Dysuria (2684); Dyspareunia (4505)

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 adverse reactions are those typically associated with surgically implantable materials, including 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 patient had a transvaginal mesh implant on ((b)(6) 2011).The patient's attorney alleged a deficiency against the device.

Manufacturer Narrative

1994, 2684, 1928 = "nl".

Event Description

Per additional information received, the patient experienced vaginal pain, slow urinary stream, dysuria, urge incontinence, hip pain, pelvic pain, sensation of a foreign body, prickling sensation, bilateral groin pain, persistent vaginal pain, discomfort, pain, voiding, bowel problems.Right hip pain, lower back pain, recurrent cystocele, mesh prolapse, difficulty evacuating her bowels, felt scarring around the posterior vaginal wall, mesh erosion, exposed ¿tvt mesh, and "folded tape" close to the urethra.Additionally, the patient required surgical and non-surgical interventions.

Event Description

Per additional information received, the patient had infection and was still suffering with urinary retention, psychiatric injury, discomfort, distress, right hip pain, groin pain, vaginal pain, pelvic pain, shooting pains, aching, difficulty in voiding bowels, foreign body sensation, prickling sensation, grade 2 cystocele, fecal incontinence, rectocele, sharp pain within the vagina radiating into the pelvis, urge incontinence, micturition urgency, constipation, recurrent vaginal prolapse, vagina was descending to about 3 cm above the vaginal introitus, vaginal bulge, concomitant cystocele on anterior wall of the vagina and recto enterocele on posterior vaginal wall, mesh erosion, vaginal discharge, avoided sexual activity, exposed mesh anteriorly, posteriorly, or at the apex, vaginal scarring, twisted mesh, pain radiating into right iliac fossa, right groin, and leg as well, stress incontinence, mucosal lesion, hiatus hernia, small bowel adhesions, significant recto enterocele, coccygeal pain, and generalized fatigue, dyspareunia, and lately raynaud¿s syndrome, prickling sensation, mesh implant failure, and additionally required surgical and non-surgical interventions.

Manufacturer Narrative

1869, 2330, 2275= "nl".

Event Description

Per additional information received on (b)(6) 2021, the patient has experienced mesh erosion, chronic pelvic pain, dyspareunia, difficulty in defecation, lower urinary tract symptoms, recurrence of the prolapse, lower abdominal, groin, and thigh pain, vaginal pain, urge incontinence, recurrent cystocele, vaginal wall prolapse, cystocele, hernia, small bowel adhesions, osteoarthritis right hip, buttock pain, bladder prolapse, sensation of foreign body, prickling sensation, problem in voiding, bowel opening, vaginal discomfort, vaginal atrophy, and required additional surgical and non-surgical interventions.

Manufacturer Narrative

1685, 2564="nl".

Manufacturer Narrative

1412, 1752, 1776, 1880="nl".H11: section a through f - 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.

Event Description

Per additional information received on 29sep2021, the patient experienced bowel adhesions, tightness of the straight leg raise and prone knee bend, headaches, sore throat and mouth, stiffness in lower back and buttocks, difficulty in walking to reach up hill, pinched feeling around mouth, chest pain, anxiety, extreme tiredness, brain fog, eye pain, difficulty in breathing, feeling of heart problems, muscles twitching in back and required additional surgical and non-surgical interventions.

• Brand Name: AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
• Type of Device: AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8828011
• MDR Text Key: 152466087
• Report Number: 1018233-2019-04221
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K082571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Catalogue Number: 486101
• Device Lot Number: CVTJ0017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 13 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 58