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

Model Number M0068317050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

E2013036.

Event Description

This manufacturer report is being sent as a requirement under summary reporting exemption approval number - e2013036 for product code otp.For the bimonthly submission due april 30, 2019, this report summarizes four (4) reported serious injury events.

• Brand Name: PINNACLE PELVIC FLOOR REPAIR KITS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA
• Manufacturer Contact: 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8562139
• MDR Text Key: 143466264
• Report Number: 3005099803-2019-02258
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: M0068317050
• Device Catalogue Number: 831-705
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1