MAUDE Adverse Event Report: ATRIUM MEDICAL PROLITE MESH; MESH, SURGICAL, POLYMERIC

Model Number	1000212-00
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To ensure the integrity of the product the device history records were reviewed to ensure the product was manufactured and inspected properly.The review of the device history records indicates that the product was manufactured and inspected properly.There were no non-conformances related to this complaint.There is not enough evidence to conclude that the mesh was the reason for the patient¿s condition.Clinical evaluation - when the muscles and ligaments supporting a woman's pelvic organs weaken, the pelvic organs can slip out of place and create a bulge in the vagina (prolapse).Women most commonly develop pelvic organ prolapse years after childbirth, after a hysterectomy or after menopause.This bulge can worsen over time.Prolite is intended for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material.Many patients experience pain in the postoperative period despite the use of pain relief techniques such as patient controlled analgesia, epidural analgesia and regional anesthesia.Prolonged pain can be defined as pain persisting for more than three months after surgery and it is a complication of many common procedures including hernia repair.Surgical technique can influence the development of chronic post-surgical pain and techniques to minimize nerve injury should be used whenever possible.Dyspareunia (painful intercourse) can occur for reasons that range from structural problems to psychological concerns.The medical term for painful intercourse is dyspareunia and is defined as persistent or recurrent genital pain that occurs just before, during or after intercourse.Some of the causes are dryness, injury, trauma, surgery, infection and congenital abnormalities.The ifu states complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection or mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines).The ifu also states adequate mesh fixation is required to minimize post-operative complications and recurrence.The fixation technique, method, and products used (including sutures, tacks, staples or other means) is left to the discretion of the surgeon to optimize clinical outcomes.
Event or Problem Description
Received report of pelvic pain, dyspareunia and pain radiating down legs that patient perceives is caused by hysteropexy mesh put in for uterovaginal prolapse in 2012.

• Brand Name: PROLITE MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8368801
• Report Number: 3011175548-2019-00224
• Device Sequence Number: 13753833
• Product Code: FTL
• UDI-Device Identifier: 00650862300031
• UDI-Public: 00650862300031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K930669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 1000212-00
• Device Catalogue Number: 1000212-00
• Device Lot Number: 10820940
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 02/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention