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

Model Number 30802

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.

Event Description

When the outer packing was opened they found some foreign matter inside the wrap.The matter was faint yellow and at the edge of the mesh.

Manufacturer Narrative

Quality control performed an inspection for foreign materials and submitted samples to the analytical chemistry department for analysis.Analytical personnel characterized the foreign material using microscopic imaging for size and shape and chemical characterization using infrared spectroscopy.Originally, gravimetric analysis was not performed for any samples due to the foreign materials being embedded into the samples.However, after ftir analysis determined that the foreign material on the mesh was fish oil, the amount of fish oil on the mesh could be determined by using a modified version of a test procedure that determines the fish oil coating density of coated mesh products.On the basis of the biological safety risk assessment for c-qur mesh, 0.072 mg of fish oil is not expected to elicit a toxicological risk to the patient.Therefore, the resulting risk of this foreign material is considered to be negligible.Clinical evaluation: it was reported that foreign matter was seen inside the package wrap.Prolite ultra 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.When a product is brought to the surgical arena and prepared for use it is inspected to insure the integrity of the packaging, the expiration dates and confirmation of the correct product size and type, etc.Is conducted between two clinicians in accordance with the safe practice recommendations provided by the joint commission.If any discrepancies are discovered the product is rejected and a new one is prepared.This may represent a delay prior to patient contact while the second product is prepared.When this step is omitted, and a product within a defective package is used it would put the patient at increased risk for infection.Any surgery that causes a break in the skin can lead to a postoperative 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 through microorganisms that are already on or in your body and then spread into the wound.If particulate is introduced into an operative site the patient may experience a foreign body or host tissue reaction, infection, pain, and/or allergic reaction or toxicity.Foreign material that is embedded in the product may cause procedure delay if noticed during set-up.If the product is used the particulate is not expected to illicit a biological response and therefore the risk is negligible.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.The ifu also states that this device is supplied sterile.Please inspect packaging to ensure it is intact and not damaged prior to use.Do not use if package is damaged or opened.

Event Description

N/a.

• Brand Name: PROLITE ULTRA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7911887
• MDR Text Key: 122041697
• Report Number: 3011175548-2018-01034
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862308020
• UDI-Public: 00650862308020
• Combination Product (y/n): N
• PMA/PMN Number: K002093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/29/2022
• Device Model Number: 30802
• Device Catalogue Number: 30802
• Device Lot Number: 424151
• Date Manufacturer Received: 10/30/2018
• Patient Sequence Number: 1