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

Catalog Number 486201

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

Patient Problems Apnea (1720); Arthritis (1723); Erosion (1750); Chest Pain (1776); Fatigue (1849); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Pain (1994); Loss of Range of Motion (2032); Abnormal Vaginal Discharge (2123); Vaginal Mucosa Damage (2124); Hernia (2240); Discomfort (2330); Injury (2348); Sore Throat (2396); Prolapse (2475); Sleep Dysfunction (2517); Dyspareunia (4505); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572)

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: 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).No sample received.

Event Description

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.

Manufacturer Narrative

1930 = "l".1994, 2123 = "nl".

Event Description

Per additional information received on 08feb2021, the patient experienced pain, suffering, loss of amenity, discoloration of discharge, infection, mesh erosion through vaginal wall, perforation, constant pain, frequent infections, pain during sexual intercourse, offensive vaginal discharge, and additionally required surgical and non surgical interventions.

Manufacturer Narrative

1941="l" 1888, 2225, 2330, 1720="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 on 20may2021, the patient experienced rectocele, bleeding, irritation, pink discharge, infection, mesh exposure to the posterior wall, recurrent mesh erosion, persistent discomfort in right side of throat and right neck, stress incontinence, obstructive sleep apnea, chronic cholelithiasis, chronic fatigue syndrome, hypercholesterolemia, atypical chest pain with negative myocardial perfusion scan and required additional surgical and non-surgical interventions.

Event Description

Per additional information received on 29sep2021, the patient experienced vaginal discharge, soreness, red loss, sore throat, cough, hernia, back pain, nausea, tiredness, arthritis, difficult social circumstances, hypersomnolence, discomfort in right side of the throat and face, right neck, prolapse and required additional surgical and non-surgical interventions.

Manufacturer Narrative

2396, 1970, 1723, 2517="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 on (b)(6) 2021, the patient has experienced sharp vaginal pain while sitting, urinary dysfunction including urinary urgency, dyspareunia, lower urinary tract symptoms, recurrence of prolapse, recurrent mesh erosion and subsequent surgery to excise the mesh, loss of mobility, difficulty in defecation, psychological impacts including social withdrawal, unspecified infection, and required additional surgical and non-surgical interventions.

Manufacturer Narrative

1871, 2032, 2564="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: AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Type of Device: AVAULTA PLUS® BIOSYNTHETIC 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: 10815879
• MDR Text Key: 215481967
• Report Number: 1018233-2020-06344
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2013
• Device Catalogue Number: 486201
• Device Lot Number: BMWB0002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2012
• 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: BARD AQUAMATICTM PTFE COATED LATEX CATHETER; PACK BOWL MEDIUM; PACK D&C/GU; VAGINAL HYST TRAY
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White