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

Catalog Number 486100

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

Patient Problems Abdominal Pain (1685); Anemia (1706); Asthma (1726); Erosion (1750); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Incontinence (1928); Itching Sensation (1943); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Vomiting (2144); Hernia (2240); Urinary Frequency (2275); Anxiety (2328); Injury (2348); Depression (2361); Disability (2371); Obstruction/Occlusion (2422); Prolapse (2475); Intermenstrual Bleeding (2665); Foreign Body In Patient (2687); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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)." 1994 = "l", 2348, 2371, 2993 = "nl".

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, disability and impairment.Product was used for therapeutic treatment.Per additional information received, the patient has experienced uterovaginal prolapse, enterocele, urinary urgency, chronic pelvic/vaginal pain, mesh embedded into vaginal tissue (foreign body in patient), scar tissue, scarring, incontinence, bleeding, pain during sexual relations, depression, anxiety, bowel obstruction, irritable bowel syndrome, hernias, hypotension/low blood pressure, obesity, cramps, pulling sensation in vagina and required additional surgical interventions.Per additional information received, the patient has experienced prolapse, incontinence, pelvic pain, bleeding, pain during sexual relations, depression, anxiety, pain, bleeding in vagina during sexual relations (intermenstrual bleeding), bowel obstruction, cystocele/rectocele (prolapse), hernias, hypotension/low blood pressure, anemia, recurrent vaginal pain, severe piercing cramps (cramp), pulling sensation (foreign body sensation), urinary incontinence, vaginal vault prolapse, failed mesh (failure of implant), and required nonsurgical interventions.Per additional information received via medical records, the patient has experienced menstrual irregularities, vaginal discharge, itching, abdominal pain, vomiting, hemorrhage, erosion, and required surgical interventions.

Manufacturer Narrative

2475, 1871, 2375 = "l".2687, 2060, 2061, 1928, 2597, 2361, 2328, 2422, 2564, 2240, 1914, 2193, 2665, 2275, 1750, 2144, 1970, 1943, 2225, 2517, 1924, 1869= "nl".H11:section a through f - the information provided by bard 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 bard.

Event Description

Per additional information received via medical records on 06oct2020, the patient has experienced menstrual irregularities, vaginal discharge, itching, abdominal pain, vomiting, hemorrhage, erosion, and required surgical interventions.Per additional information received via medical records on 20apr2022, the patient has experienced vaginal pain and bleeding, chronic pelvic pain, dyspareunia, urinary urgency, urgency urinary incontinence, rectal bulge, and urinary frequency.

Event Description

Per additional information received via medical records on 14jun2022, the patient has experienced urgency of urination, vaginal atrophy, urgency incontinence, high-tone pelvic floor dysfunction, exposure of implanted vaginal mesh and prosthetic material in vagina, sequela, nocturia, fecal smearing, post coital bleeding, pelvic pain and dyspareunia.

Manufacturer Narrative

H11:section a through f - the information provided by bard 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 bard.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.

Manufacturer Narrative

Correction: a,g.1685, 1706, 1726, 1888, 1959, 2519, 2357, 3191= "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 via medical records on 14dec2023, the patient had experienced bladder leaking, uterine prolapse, bowel obstruction, incontinence, pelvic pain, vaginal bleeding, pain during sexual relations (dyspareunia) and rectal pain, depression, anxiety, anemia, asthma, menorrhagia, metrorrhagia, dysmenorrhea, vaginal pain, vaginal atrophy, vaginal mesh exposure, frequency, fecal smearing, post coital bleeding, urge urinary incontinence, stress, sexual dysfunction, genital pain and required additional surgical and non-surgical treatments.

• Brand Name: AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR
• Type of Device: AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR
• 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: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10720825
• MDR Text Key: 213921880
• Report Number: 1018233-2020-06331
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 00801741168024
• UDI-Public: (01)00801741168024
• 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,Followup,Followup,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2012
• Device Catalogue Number: 486100
• Device Lot Number: HUUG2124
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2010
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic