MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PFR KIT UPHOLD LITE VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068317170

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

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Dyspareunia (4505)

Event Date 08/21/2012

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2012, implant procedure date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The complainant indicated that the device is not available for return; therefore, analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this manufacturer report pertains to the first of second devices used during the same procedure.It was reported to boston scientific corporation that a pfr kit pinnacle lite posterior and pfr kit uphold lite vaginal support system device were implanted into the patient during an anterior uphold mesh repair and posterior pinnacle repair procedure on (b)(6) 2012, for the treatment of cystocele and rectocele.The patient experienced complications following the procedure.Eep (erosion/extrusion/protrusion of the mesh), back pain, vaginal pain, anal pain, painful intercourse, inability to have intercourse, offensive vaginal discharge, difficulties with bowel motions, recurrent incontinence are among the symptoms of the patient.Nonsurgical treatments: on (b)(6) 2021, the patient commenced topical treatment (including estrogen cream): ovestin cream for the treatment of: thicken virginal wall.Treatment duration: on going.

• Brand Name: PFR KIT UPHOLD LITE VAGINAL SUPPORT SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15195623
• MDR Text Key: 297570814
• Report Number: 3005099803-2022-04385
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2022

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: 12/31/2014
• Device Model Number: M0068317170
• Device Catalogue Number: 831-717
• Device Lot Number: ML00000431
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 52 KG