MAUDE Adverse Event Report: PREFYX PPS SYSTEM; MESH, SURGICAL, POLYMERIC

Model Number UNK335

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

(b)(4).Submissions for product codes otp and pah can be found under manufacturer reports numbers 3005099803-2016-04062 and 3005099803-2016-04063.

• Brand Name: PREFYX PPS SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6195339
• MDR Text Key: 63066648
• Report Number: 3005099803-2016-04061
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNK335
• Type of Device Usage: N
• Patient Sequence Number: 1