MAUDE Adverse Event Report: UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068317080

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This manufacturer report is being sent as a requirement under summary reporting exemption approval number ¿ (b)(4) for product code otp.Please see attached spreadsheet for the bimonthly submission due (b)(6) 2018.Submissions for product codes otn and pah can be found under manufacturer reports numbers 3005099803-2018-2176 and 3005099803-2018-02170.

• Brand Name: UPHOLD VAGINAL SUPPORT SYSTEM
• 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: 7650704
• MDR Text Key: 112743693
• Report Number: 3005099803-2018-02171
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K081048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 03/21/2018

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: M0068317080
• Device Catalogue Number: 831-708
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2018
• Type of Device Usage: N
• Patient Sequence Number: 1