MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH POLYFORM SYNTHETIC MESH; MESH, SURGICAL, POLYMERIC

Model Number M0068402400

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

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a boston scientific device was implanted during a posterior vaginal wall repair and sacrospinous fixation with mesh procedure on (b)(6) 2013.According to the complainant, the patient experienced an unknown injury.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: POLYFORM SYNTHETIC MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7582441
• MDR Text Key: 110482997
• Report Number: 3005099803-2018-01837
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: M0068402400
• Device Catalogue Number: 840-240
• Device Lot Number: C001447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other