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

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

We have received a report that a physician implanted a prolite mesh, with an expired expiration date.With no injury to patient.

Manufacturer Narrative

Investigation: based on the details of the complaint the institution placed the prolite mesh and after the procedure noticed that the mesh had expired.The handling and storage of the product is the responsibility of the institution.Atrium medical corporation cannot guarantee the performance or the sterility after the product has expired.In this case the product had expired in march of 2020.As the lot number was not provided the exact expiration date is not known.All prolite mesh products have the expiration date located on the product label and have a 5 year shelf life from the time of manufacture.Clinical evaluation: the prolite mesh product is supplied sterile inside a pouch inside a box that are both labeled with expiration dates.Hospital guidelines require close monitoring of the products that are held in stock to prevent aging products from remaining on the shelf.A second mechanism is at the procedure table.Prior to entry onto the sterile field the expiration date should be confirmed and recorded.In the case where an expiration date has passed and the product is used there would be no guarantee of sterility of that product.

Event Description

N/a.

• Brand Name: PROLITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10178328
• MDR Text Key: 195896247
• Report Number: 3011175548-2020-00840
• Device Sequence Number: 1
• Product Code: FTL
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/14/2020
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other