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

Model Number M0068402400

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

Patient Problem Insufficient Information (4580)

Event Date 04/28/2010

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2010, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2401 - unspecified personal injury.The following imdrf impact code capture the reportable event of: f12 - patient had sought for a legal recourse for injuries related to the device.

Event Description

It was reported to boston scientific corporation that a polyform graft device was implanted into the patient during a total vaginal hysterectomy procedure performed on (b)(6) 2010, for the treatment of symptomatic uterine prolapse.The procedure revealed a grade 3-cystocele, a grade 1-rectocele, a grade 2-vaginal vault prolapse, and normal intraurethral and intravesical anatomy.A normal spill of indigo-carmine-tinted urine was noted bilaterally.There is no evidence of bladder or urethral injury.Normal rectal examination.The patient was subsequently awakened, extubated, and taken to the recovery room for routine postoperative care.As reported by the patient's attorney, the patient has experienced an unspecified injury.

• Brand Name: POLYFORM SYNTHETIC MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17093100
• MDR Text Key: 316849698
• Report Number: 3005099803-2023-02954
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: M0068402400
• Device Catalogue Number: 840-240
• Device Lot Number: C001032
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female