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

Catalog Number 486200

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

Patient Problems Irritation (1941); Abnormal Vaginal Discharge (2123); Injury (2348)

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: ¿complications associated with the proper implantation of the avaulta solo¿ synthetic support 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, 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

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced vaginal irritation, chronic vaginal discharge, odor and itching, vaginitis, vulvovaginitis, genital culture with heavy growth of e.Coli, serous drainage, chronic anterior mesh exposure, recurrent cystocele, recurrent rectocele, vaginal infection, dyspareunia, pain deep in vagina, chronic infection, recurrent prolapse, nocturia, difficulty starting stream, slow or weak stream, wear pads all the time, difficulty emptying rectum, alternating constipation and diarrhea, difficulty voiding, vaginal bleeding after sex, vaginal pressure, palpable bulge at introitus, urogenital atrophy, granulation tissue at left vaginal sulcus, blood in urine [hematuria], mesh erosion, chronic pelvic pain, pelvic pressure, sensation of incomplete bladder emptying, mild trabeculations, descent of uterus, left-sided perforation of the dome of the bladder during mesh and sling placement on ((b)(6) 2012), vaginal scarring, stress incontinence, urinary frequency, urgency and required multiple surgical and nonsurgical interventions.

• Brand Name: AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Type of Device: AVAULTA SOLO® SYNTHETIC 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: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8915250
• MDR Text Key: 155035379
• Report Number: 1018233-2019-04878
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 00801741168031
• UDI-Public: (01)00801741168031
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2012
• Device Catalogue Number: 486200
• Device Lot Number: HUUE0751
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 13 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2010
• 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
• Treatment: AVAULTA SOLO ANTERIOR SYNTHETIC SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 69