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

Catalog Number 486200

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

Patient Problems Laceration(s) (1946); Pain (1994); 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: ¿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 by the patient¿s attorney that as a result of having the product implanted, the patient has experienced pain, laceration of internal body tissue and organs, dyspareunia, dysuria, painful/permanent scarring, permanent bodily disfigurement, impairment/damage, sequelae, erosion of internal bodily tissue, injury, additional surgeries and corrective treatment.Product was used for therapeutic treatment.Per additional information received, the patient has experienced vaginal mesh extrusion, reproducible pain with palpitation, dyspareunia, vaginal pain, rectocele, attenuated rectovaginal fascia, mesh erosion through rectal mucosa, foreign material present, focal giant cell reaction, mesh exposure, rectocele without mention of uterine prolapse, anovaginal fistula, perirectal hematoma, questionable abscess, acute pain, swelling in the vaginal and right buttock cheek and perineal area, and required surgical and non-surgical 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: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10870712
• MDR Text Key: 217463361
• Report Number: 1018233-2020-06354
• 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: 11/19/2020

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: 11/01/2011
• Device Catalogue Number: 486200
• Device Lot Number: HUUA0195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2010
• 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: 44 YR