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

Catalog Number UGYKP

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Abdominal Pain (1685); Erosion (1750); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Unspecified Infection (1930); Urinary Retention (2119); Urinary Frequency (2275); Swelling/ Edema (4577)

Event Date 10/25/2007

Event Type  Injury  

Event Description

According to the reporter: following a posterior mesh procedure in which the posterior mesh and boston scientific corporation's obtryx transobturator vaginal sling was implanted for the treatment of pelvic organ prolapse and stress urinary incontinence, the patient allegedly experienced pain and injuries, including, but not limited to, erosion of the vaginal wall and other tissues, infection, vaginal bleeding, severe abdominal pain and swelling, increase in urinary frequency and difficulty emptying her bladder.The patient underwent subsequent surgeries, including excision of the mesh on (b)(6) 2007, (b)(6) 2008, (b)(6) 2008, and (b)(6) 2008.Plaintiff has undergone or will undergo further corrective surgery or surgeries.

• Brand Name: PARIETEX UGYTEX PP POSTERIOR KIT X1
• Type of Device: AVUALTA BIOSYNTHETIC POSTERIOR 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; trevous F-016 00
• Manufacturer Contact: terry callahan ; 60 middletown ave; north haven, CT 06473 ; 2034926273
• MDR Report Key: 5377791
• MDR Text Key: 292992783
• Report Number: 1018233-2010-00015
• 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
• Report Date: 02/04/2010

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 Catalogue Number: UGYKP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female