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

Model Number 1000306-00

Device Problem Device Expiration Issue (1216)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Hospital reported that they had implanted a prolite mesh 3-4 months past its expiration date.

Manufacturer Narrative

In the product complaint, the hospital had implanted a mesh that had been expired (according to the pouch label) by 3 to 4 months.Through correspondence from the hospital, time was not taken to check the expiration date of the product.However, there was a note that "the product was in a box that had an expiration date of 2017".So the investigation will look to see if the labels for the product are correct.Engineering looked at the device history record (dhr) for the lot in question.Per procedure manufacturing prints the first label of the lot and attaches it to the dhr for qc review and approval.The top part of the attached label is the box label while the bottom part is the pouch label.The expiration date 2016/03 is the same on both labels.The rest of the information like lot number, part number and size are the same as well.The dhr information matches the label information as well.The dhr does not have any record of re-printed labels or rejects for bad labels (which would require a label reprint) so there is no evidence that the box and pouch labels could have different expiration dates.The review of the dhr shows that the box and pouch labels have the correct expiration date and that the information matches on both labels.Because the packaging is not being returned, there is no evidence to suggest that the labels were different or had a different expiration date.Without the packaging to confirm the assertion made by the hospital, engineering cannot conclude that there was a discrepancy in box and pouch labels.According to the documentation, the labels matched and the expiration date of 2016/03 is correct.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.The instructions for use precaution that the device is provided sterile, for one procedure only.Do not re-sterilize.Use prior to the expiration date noted on the package.

• Brand Name: PROLITE 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: 5853764
• MDR Text Key: 52426715
• Report Number: 1219977-2016-00181
• Device Sequence Number: 1
• Product Code: FTL
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2016
• Device Model Number: 1000306-00
• Device Catalogue Number: 1000306-00
• Device Lot Number: 10735740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2016
• Initial Date FDA Received: 08/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2011
• 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 Age: 76 YR
• Patient Weight: 90