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 Material Twisted/Bent (2981)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Anxiety (2328); Injury (2348); Prolapse (2475); No Code Available (3191)

Event Date 10/08/2014

Event Type  Injury  

Manufacturer Narrative

Report source: other: tga device incident report reference no (b)(4); submitted to tga (therapeutic goods administration) by the patient.(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a pfr kit uphold lite vaginal support system device was implanted into the patient during a procedure on (b)(6) 2013.According to the patient, after the implantation, the patient experienced mesh erosion through her vagina, prolapse, nerve pain, pelvic infection, incontinence, autoimmune symptoms, pain in defecation, thyroid nodules, hyperthyroid, bleeding, infection in the vagina where the mesh eroded, anxiety and panic attacks.It was also reported that the mesh was buckling and distorted.Subsequently, the patient underwent mesh removal on (b)(6) 2020 and hemithyroid surgery.Boston scientific has been unable to obtain additional information regarding the event to date.

• 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: 11153236
• MDR Text Key: 226259212
• Report Number: 3005099803-2020-06637
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: M0068317170
• Device Catalogue Number: 831-717
• Device Lot Number: ML00000945
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention