MAUDE Adverse Event Report: INSIGHTRA MEDICAL FREEDOM PROFLOR; SURGICAL MESH

Model Number FIHR 40MME

Device Problems Material Rupture (1546); Device Issue (2379)

Patient Problems Hernia (2240); Patient Problem/Medical Problem (2688)

Event Date 12/03/2015

Event Type  malfunction  

Event Description

It was reported that a doctor was using a 40mme proflor hernia repair implant for the first-time and experienced a separation of the preperitoneal disk separation while deploying the implant into the preperitoneal space.The doctor used a 40mm delivery instrument for deploying the implant and then used surgical forceps to fully position the preperitoneal disk into the desired location.After the preperitoneal disk separation occurred, the doctor removed the implant from the patient.The doctor then used a 25mme hernia repair implant to complete the procedure without any problems.The failed product was disposed of by the customer and is not available for return.No images of the torn implant were available for evaluation.

• Brand Name: FREEDOM PROFLOR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): INSIGHTRA MEDICAL; 9200 irvine center drive; suite 200; irvine CA 92618
• Manufacturer Contact: thomas colonna ; 9200 irvine center drive; suite 200; irvine, CA 92618 ; 9492151835
• MDR Report Key: 5320678
• MDR Text Key: 34199362
• Report Number: 2032677-2015-00020
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/22/2018
• Device Model Number: FIHR 40MME
• Device Catalogue Number: FIHR 40MME
• Device Lot Number: 05221513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/22/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 91