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

Model Number M0068318170

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

Patient Problem Insufficient Information (4580)

Event Date 03/21/2016

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an uphold lite device was implanted into the patient during anterior repair with uphold, posterior repair and cystoscopy procedure performed on (b)(6) 2016.After the procedure, the patient has experienced an unspecified injury.

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2016 was chosen as a best estimate based on the date of the mesh was implanted.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.

• Brand Name: UPHOLD LITE
• 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: 14333318
• MDR Text Key: 291199750
• Report Number: 3005099803-2022-02309
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/08/2022

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: 11/10/2018
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00003298
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female