MAUDE Adverse Event Report: SOFRADIM PRODUCTION AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

Catalog Number 486020

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

Patient Problems Erosion (1750); Unspecified Infection (1930); Blood Loss (2597)

Event Type  Injury  

Event Description

Per additional information received, the patient has experienced erosion, infection, urinary problems, bowel problems, recurrence, bleeding, dyspareunia and chronic urgency.

Manufacturer Narrative

(b)(4).The total number of events for product classification code otp is 36.Qty 5- avaulta plus biosynthetic support system.Qty 10- avaulta plus biosynthetic support system - anterior, sterile.Qty 10- avaulta plus biosynthetic support system - posterior, sterile.Qty 7- avaulta solo synthetic support system - anterior, sterile.Qty 4- avaulta solo synthetic support system - posterior, sterile.The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.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 complications associated with the proper implantation of the avaulta plus biosynthetic support system 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, rejection of biologic materials, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of vaginal wall prolapse.Urinary incontinence (stress and urge).(b)(4).

Manufacturer Narrative

(b)(4).Original reporting time frame from (b)(6) 2013.This file was previously reported as a bard product under exemption (b)(4).Per additional information received, it was determined that this product was manufactured by (b)(4).(b)(4) has been notified and any additional information received will be reported by them.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.

• Brand Name: AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• Type of Device: AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; 01600 trevoux, GA 30014 ; FR 30014
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; 01600 trevoux, GA 30014 ; FR 30014
• Manufacturer Contact: christy lewis ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 3596039
• MDR Text Key: 4092134
• Report Number: 1018233-2014-00018
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Catalogue Number: 486020
• Device Lot Number: ZGC00716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/04/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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