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

Model Number 31633

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 03/21/2016

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

It was reported by a surgeon that his patient had a skin reaction after implant of a surgical mesh.The reaction was noted on the patient's posterior and was considered to be caused by the hospital bedding and equipment.Eight months post procedure the patient returned to the physician's office with a rash that he thought was at the edge of the implanted mesh.A ct scan revealed no apparent fluid accumulation and the mesh was well incorporated with no signs of bowel injury.Patient treated with steroid cream.

Manufacturer Narrative

A review of lot history and sterilization records was performed.The finished good and subassembly lots passed all in-process inspections and testing including but not limited to fourier transform infrared spectroscopy and seal strength on pre and post sterile pouches.All raw materials met all incoming testing and inspections.Review shows that this lot met all sterilization and manufacturing acceptance criteria for lot release.Clinical evaluation: clinical evaluation: a rash is a noticeable change in the texture or color of the skin.The skin may become scaly, bumpy, itchy, or otherwise irritated.There are numerous causes for rashes, including: exposure to an irritant or another foreign substance.Possible irritants could be laundry detergent, personal hygiene products, chemicals or poisonous plants.The resulting rash may be itchy and red or inflamed.A rash may also indicate infection.Microorganisms can infect a surgical wound through various forms of contact, such as from the touch of a contaminated caregiver or surgical instrument, through microorganisms in the air or in your body.Any infection will cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling.Other risks for infection include a compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes.Most surgical site infections can be treated successfully with antibiotic medications.It states in adverse reactions, "complications that may occur with the use of any surgical mesh include, but are not limited to inflammation and infection.

• Brand Name: C-QUR TACSHIELD MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH
• Manufacturer Contact: theresa morin ; 40 continental blvd; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 5555054
• MDR Text Key: 42089138
• Report Number: 1219977-2016-00060
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: 31633
• Device Catalogue Number: 31633
• Device Lot Number: 207844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2014
• 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
• Patient Age: 64 YR
• Patient Weight: 98