MAUDE Adverse Event Report: ATRIUM MEDICAL C-QUR TACSHIELD; MESH, SURGICAL, POLYMERIC

Model Number 31633

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

A full review of all manufacturing lot history records was performed and no deficiencies were noted during the review.All the records indicate that the product in question met the product requirements.Clinical evaluation: c-qur tacshield is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.A seroma is a collection of fluid that builds up under the surface of your skin.Seromas may develop after a surgical procedure, most often at the site of the surgical incision or where tissue was removed.The fluid, called serum, doesn¿t always build up right away.The swelling and fluid may start collecting several weeks after surgery.A large seroma may need to be drained.Seromas can return and may need to be drained multiple times.Occasionally a procedure may need to be performed to remove the seroma and/or explant the mesh.Seroma post implant of any mesh product may be caused by improper fixation methods.Careful attention to proper fixation techniques and sizing of the product should be taken to help prevent excessive tension or disruption between the mesh material and tissue.The instructions for use (ifu) states complications that may occur with the use of any surgical mesh include, but are not limited to, pain, inflammation, infection, allergic reaction, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera and other organs.The patient should be advised to contact the physician should an adverse reaction occur.

Event Description

Received a report one surgeon has reported post-operative ellipses with tissue deficit.Reported with no other post-operative complications.

• Brand Name: C-QUR TACSHIELD
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7302945
• MDR Text Key: 101163708
• Report Number: 3011175548-2018-00194
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K100076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2018
• Device Model Number: 31633
• Device Catalogue Number: 31633
• Device Lot Number: 403776
• Other Device ID Number: 00650862316339
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2018
• Date Device Manufactured: 01/26/2016
• 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