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

Model Number FIHR 25MM

Device Problem Material Rupture (1546)

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

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

It was reported that a customer experienced a preperitoneal disk separation from the core of a proflor implant, model fihr 25mm, when attempting to repair a 15mm hernia defect.Based on the report, the proflor implant lamella was being placed in the hernia orifice when the preperitoneal disk separation occurred.Another fihr 25mm proflor implant from the same lot was used to successfully complete the procedure.There was no reported patient harm.

Event Description

It was reported that a customer experienced a preperitoneal disk separation from the core of a proflor implant, model fihr 25mm, when attempting to repair a 15mm hernia defect.Based on the report, the proflor implant lamella was being placed in the hernia orifice when the preperitoneal disk separation occurred.Another fihr 25mm proflor implant from the same lot was used to successfully complete the procedure.There was no reported patient harm.

• Brand Name: FREEDOM PROFLOR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): INSIGHTRA MEDICAL; 9200 irvine center drive; irvine CA 92618
• Manufacturer (Section G): INSIGHTRA MEDICAL; 9200 irvine center drive; irvine CA 92618
• Manufacturer Contact: thomas colonna ; 9200 irvine center drive; irvine, CA 92618 ; 9492151835
• MDR Report Key: 6115886
• MDR Text Key: 60422763
• Report Number: 2032677-2016-00010
• 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: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

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: 09/25/2017
• Device Model Number: FIHR 25MM
• Device Catalogue Number: FIHR 25MM
• Device Lot Number: 09251411
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2014
• 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: 38 DA
• Patient Weight: 68