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

Model Number	1010202-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the device in question was not returned and no images provided it is difficult to determine the root cause of the complaint.The details provided indicate that the physician was using the tab as an anchor.The tab itself when welded in manufacturing is tested to an aql level to ensure the integrity of the weld.The manufacturing lot history records show that this lot of mesh passed the tensile test requirements.To ensure the integrity of the product all device history records were reviewed to ensure the product was manufactured and inspected properly.The review of the device history records indicates that the product was manufactured and inspected properly.Based on the details of the complaint, atrium medical cannot conclude that the mesh was faulty.If a product does not perform the way it is intended it could create a procedural delay.A delay during a procedure would impact the patient by prolonging anesthesia time and length of immobility on the table.
Event or Problem Description
Received a call from a hospital that the surgeon was doing a hernia repair and using the tab as an anchor.The tab pulled off.No patient injury.

• Brand Name: PROLITE MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8290579
• Report Number: 3011175548-2019-00131
• Device Sequence Number: 1733962
• Product Code: FTL
• UDI-Device Identifier: 00650862301021
• UDI-Public: 00650862301021
• Combination Product (Y/N): N
• Initial Reporter State: MO
• PMA/510(K) Number: K930669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2023
• Device Model Number: 1010202-01
• Device Catalogue Number: 1010202-01
• Device Lot Number: 432632
• Was Device Available for Evaluation?: No
• Device Age: YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR