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

Catalog Number 486100

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

Patient Problems Pain (1994); Hernia (2240); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced pain, disability and impairment.Per additional information received, the patient has experienced complications from mesh requiring excision of mesh, anterior repair, laparoscopic hysterectomy, bilateral salpingo-oophorectomy, laparoscopic colpopexy (suture only) on ((b)(6) 2014), pelvic pain, dyspareunia, pain with bending and squatting, cystocele, hernias, pelvic tumors or fibroids, rectocele, recurrent vaginal pain, uterine prolapse and vaginal vault prolapse.The patient has experienced mesh erosion, uterine prolapse, pelvic pain, dyspareunia, dense scar plating around the mesh/dense band of scar tissue along the anterior vaginal wall just inside the introitus at the level of the mid distal urethra, severe abdominal pain, headaches, constant pelvic discomfort, contracted mesh, chronic pain, mesh embedded deeply in tissue (foreign body in patient), and required additional surgical and non surgical interventions.The patient has experienced mesh complications, prolapse, pelvic discomfort, dyspareunia, vaginal pulling sensation (foreign body sensation), difficulty emptying bladder, elevated blood pressure, tenderness, foreign body in patient, pelvic pain, erosion, scarring (scar tissue), defect, blood loss, adenomyosis, leiomyomas, inflammation, endometriosis, nodules, ovarian atrophy, fibrosis, hematoma, spotting, pink discharge, vaginal pain, anemia, abdominal pain, headache, pain, vaginal bleeding, nonsurgical and additional surgical interventions.The patient has experienced postoperative urinary retention, vulvodynia, left lower quadrant pain, bulge discomfort with increasing heaviness, back pain, stage 2 uterine prolapse with the cervix protruding out about 1 cm past the introitus, banding in the anterior graft and pain at the site where it inserts and the right levator ani muscles, banding on the left side, scarred and shortened anterior vaginal wall, ¿pulling¿ sensation to the urethral area, possible urinary tract infection, back spasm, difficult time emptying her bladder on occasion, palpable mesh along the anterior vaginal wall, mesh tight and very tender to examination, dense scar plating around the mesh, urine frequency, urgency, flank pain, constipation, vaginal atrophy, persistent mesh as well as damage to the adjacent tissues, mesh folded and contracted on itself bilaterally and findings consistent with nerve entrapment, dense scarification, and impingement upon adjacent tissues, bladder pain, and chronic mesh pain, anxiety arising from the complications of mesh and loss of consortium.

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: adverse reactions 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.2993, 2371, 2240, 1994 = "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.

• Brand Name: BARD AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM
• Type of Device: BARD AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9800143
• MDR Text Key: 187854397
• Report Number: 1018233-2020-01607
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 00801741168024
• UDI-Public: (01)00801741168024
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2011
• Device Catalogue Number: 486100
• Device Lot Number: HUTF0676R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 19 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RUINER 10-FRENCH SUPRAPUBIC CATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 72