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

Model Number M0068317080

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

Patient Problem Erosion (1750)

Event Date 05/26/2015

Event Type  Injury  

Manufacturer Narrative

Date of event is approximated to (b)(6) 2015, device revision date, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representation.The implanting surgeon is (b)(6).Revision surgery performed by(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a uphold implant was implanted into the patient during an anterior pinnacle uphold mesh plus cystoscopy post colporrhaphy on (b)(6) 2011, for the treatment of cystocele, rectocele and enterocele.Surgical interventions: on (b)(6) 2015, patient underwent excision of vaginal mesh, cystoscopy for mesh erosion.

• Brand Name: UPHOLD 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: 15986899
• MDR Text Key: 305510290
• Report Number: 3005099803-2022-07329
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081048
• 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: 12/15/2022

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: 02/28/2014
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Device Lot Number: 1ML1022205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2011
• 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: 68 YR
• Patient Sex: Female