MAUDE Adverse Event Report: SOFRADIM PRODUCTION PCO VENTRAL PATCH 8C

Model Number PCO8VP

Device Problem Insufficient Information (3190)

Patient Problem Hernia (2240)

Event Date 09/25/2013

Event Type  Injury  

Event Description

Clinical study: according to the reporter: on (b)(6) 2013, the patient had the mesh implanted.On (b)(6) 2014, the patient experienced recurrence of the hernia.The outcome is currently ongoing.According to the principal investigator, the relationship to the device is possible.Medical history: (b)(6), nephropathy, hypertension.

Manufacturer Narrative

(b)(4).

• Brand Name: PCO VENTRAL PATCH 8C
• Type of Device: PCO VENTRAL PATCH
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06743 ; 2034925267
• MDR Report Key: 4272492
• MDR Text Key: 5229453
• Report Number: 9615742-2014-00337
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCO8VP
• Device Catalogue Number: PCO8VP
• Device Lot Number: PNE0116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2014
• 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): Other