MAUDE Adverse Event Report: PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068317100

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

The manufacturer report is being sent as a requirement under summary reporting exemption approval number - (b)(4) for product code otp.Submissions for product codes otn and pah can be found under manufacturer reports numbers 3005099803-2016-04061 and 3005099803-2016-04063.

• Brand Name: PINNACLE PELVIC FLOOR REPAIR KITS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6195494
• MDR Text Key: 63064571
• Report Number: 3005099803-2016-04062
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K071957
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: M0068317100
• Device Catalogue Number: 831-710
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2016
• Type of Device Usage: N
• Patient Sequence Number: 1