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

Catalog Number 486100

Device Problem Defective Component (2292)

Patient Problems Micturition Urgency (1871); Unspecified Infection (1930); Urinary Frequency (2275); Insufficient Information (4580)

Event Type  Injury  

Event Description

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

Manufacturer Narrative

Tracking number: (b)(4).

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 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.

Event Description

Per additional information received, the patient has experienced leakage of urine, recurrent stress incontinence and intrinsic sphincter dysfunction requiring cystoscopy and periurethral injection of macroplastique bulking agent as well as tvt exact with adjustable suture, frequency, urgency, difficulties with constipation, probable scarring of bladder neck, nocturia, increased abdominal pressure, trial bladder training program, cystitis, and recurrent bladder and urinary infections, 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.

Event Description

Per additional information received, the patient has experienced intrinsic sphincter deficiency and required additional surgical interventions.

• Brand Name: AVAULTA SOLO SYNTHETIC SUPPORT SY'STEM - 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; lot #1, road #3, km 79 7; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6957882
• MDR Text Key: 291728278
• Report Number: 1018233-2013-00407
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2013,10/18/2017

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: 03/31/2011
• Device Catalogue Number: 486100
• Device Lot Number: HUTB2004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2013
• Distributor Facility Aware Date: 01/16/2013
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2013
• Initial Date Manufacturer Received: 01/21/2013
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 09/09/2014; 10/04/2017
• Supplement Dates FDA Received: 10/08/2014; 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AVAULTA SOLO SNTHETIC SUPPORT SYSTEM - POSTERIOR; MINIARC SLING
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 74 KG