MAUDE Adverse Event Report: TREVOUX - USS PARIETEX UGYTEX PP ANTERIOR KIT X1; AVAULTA ANTERIOR BIOSYNTHETIC SYSTEM

Catalog Number UGYKA

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

Patient Problems Erosion (1750); Inflammation (1932); Pain (1994); Injury (2348); Blood Loss (2597); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Us surgical reference #: (b)(4).Date of initial report sent: (b)(6) 2009.Note: this report corresponds with bard's report #: (b)(4) for an "avaulta anterior system", product id: 486010.

Event Description

Procedure type: urological.According to the reporter: the patient underwent an anterior repair procedure for treatment of pelvic organ prolapse.Allegedly, the patient experienced pain and injury.The device remains implanted.Patient has undergone or will undergo corrective surgery or surgeries.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Per additional information received, as a result of having the product implanted, the patient has experienced mesh erosions, constriction syndrome posteriorly and painful intercourse.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

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 blood loss, bleeding, oozing, mesh exposure, mesh extrusion, mucosa/thinning of mucosa, palpable mesh, discomfort in leg with traction, bands of mesh/feels radiating laterally, pain, pelvic/vaginal pain, dyspareunia, ¿notices something is sticking out of the right side her labia¿/sutures on right labia (foreign body in patient), weight loss, firmness to introductory site of vagina, emotional breakdown, numbness in left leg, palsy secondary to injection, easy bruising, injection running out of the vaginal area, upset, mesh reaction (foreign body reaction), scarred tissue, inflammation, stress, anxiety, pain right buttocks/thigh, roughness around the suburethral area/mucosa, bacterial vaginosis, headaches, thigh pain/inner thigh turn red, interfering with quality of life/ability to work/has to take frequent breaks/intolerable intercourse, posterior wall defect, visible mesh, vaginal discharge, fevers, decrease in appetite, not getting enough sleep, cellulitis, anemia, hemoglobin dropped/low postoperatively, low red blood cell count, hematocrit low, foreign body/vaginal mesh, granulation tissue, non-surgical and additional surgical interventions.

• Brand Name: PARIETEX UGYTEX PP ANTERIOR KIT X1
• Type of Device: AVAULTA ANTERIOR BIOSYNTHETIC SYSTEM
• Manufacturer (Section D): TREVOUX - USS; 116 avenue du formans; trevoux F-016 00; FR F-01600
• Manufacturer (Section G): TREVOUX - USS; 116 avenue du formans; trevoux F-016 00; FR F-01600
• Manufacturer Contact: terry callahan ; 60 middletown ave.; north haven, CT 06473 ; 2034926273
• MDR Report Key: 5287821
• MDR Text Key: 143071530
• Report Number: 1018233-2009-00158
• Device Sequence Number: 1
• Product Code: OTP
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/10/2015,11/11/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Catalogue Number: UGYKA
• Device Lot Number: ZGI00104
• 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: 12/10/2015
• Distributor Facility Aware Date: 11/11/2015
• Date Report to Manufacturer: 12/10/2015
• Initial Date Manufacturer Received: 12/02/2009
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: 11/11/2015; 11/11/2015; 11/11/2015; 11/11/2015
• Supplement Dates FDA Received: 02/08/2012; 02/29/2012; 05/22/2012; 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 77