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 Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Injury (2348); Prolapse (2475); Dysuria (2684)

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 injury, pain, discomfort, urinary problems, dyspareunia, additional surgeries, erosion and urinary incontinence.Product was used for therapeutic treatment.Per additional information received via follow-up on 30 sep 2020, the patient experienced disability and required surgical and non-surgical interventions.

Manufacturer Narrative

2475="l".2120, 2684, 1888= "nl".

Event Description

Per additional information received via medical records on 12apr2021, the patient experienced chronic pain in the lower abdomen, uterus prolapse, increases frequency of urination, hurts to urinate, urinary tract infections, vaginal bleeding after sexual intercourse, vaginal atrophy, dysuria, cystitis which required 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
• MDR Report Key: 10659343
• MDR Text Key: 210718485
• Report Number: 1018233-2020-06329
• 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
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• 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: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC.; UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 74