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

Model Number 1000606-00

Device Problems Use of Device Problem (1670); Expiration Date Error (2528)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer call from mercy health, they had used the mesh on a patient and it was beyond the usage date.Requested information on using prolite mesh after the specified date.Not known if they knew it was old or if they didn't realize it at the time.

Manufacturer Narrative

Customer call from mercy health, they had used the mesh (1000606-00) on a patient and it was beyond the usage date.Requested information on using prolite mesh after the specified date.Not known if they knew it was old or if they didn't realize it at the time.Based on the details of the complaint an expired prolite mesh had been implanted after the product expiration date of 11 july 2022.The product in question has a 5 year expiration date and had been manufactured on 13 jul 2017.The expiry dating (five years from the date of manufacture) on this product is based upon the testing we have performed to assure the product¿s performance when it is first implanted.In particular, the dating focuses on packaging integrity to assure sterility, as well as the successful deployment and fixation of the mesh.Once implanted, this product is intended to be a permanent implant, which is supported by clinical experience and the use of well-established materials.We cannot comment on the sterility and product performance when used beyond the labeled expiration date, as we do not have testing on file to support such claims.If the integrity of the device and its packaging were to be compromised, adverse reactions, as noted in the product¿s instructions for use, can occur.The instructions for use does instruct the user to inspect both the packaging and the mesh for damage prior to use.The label of the product that is on the outside of the box clearly shows the expiration date.There is also additional labeling inside the product box that also provides the product expiration date.The multiple patient peel-off labels also provide the product expiration date.A device history record review was conducted within the finished good product lot 417716.The review shows that the attached label within the dhr has the proper expiration date based on the manufacture date of the product.When the box label is printed in manufacturing for the lot the label expiration date of 5 years from the time of printing the label is automatically applied by scanning the bar code of the dhr.This was conducted following manufacturing procedure mp000005 label generation, revision be at the time of manufacture.The first and last label printed are verified to ensure the expiration date is correct.The dhr shows that the labels were printed on 11 jul 2017 and coincides with the printed label expiration date of 2022-07-11.Based on the details provided the complaint cannot be confirmed as the implant date of the device was not provided by the complainant.Use of the device after the expiration date that is clearly printed on the product label is considered user error.The hospital staff who is prepping the product for use is responsible to ensure the product being used has not exceeded its shelf life.The root cause of the complaint is considered user error as the product expiration date was not verified by the user prior to use.H3 other text : device not available for return.

• Brand Name: MESH PROLITE SHEETS
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 15360718
• MDR Text Key: 305341171
• Report Number: 3011175548-2022-00250
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862300079
• UDI-Public: 00650862300079
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2022
• Device Model Number: 1000606-00
• Device Catalogue Number: 1000606-00
• Device Lot Number: 417716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1