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

Model Number	M0068318170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2016, implant 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 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 identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an uphold lite device was implanted into the patient during a procedure for repair of enterocele and perineal body + cystoscopy performed on (b)(6) 2016 for treatment of prolapse.As reported by the patient's attorney, the patient experienced an unknown injury.
Event or Problem Description
It was reported to boston scientific corporation that an uphold lite device was implanted into the patient during a procedure for repair of enterocele and perineal body + cystoscopy performed on (b)(6) 2016 for treatment of prolapse.As reported by the patient's attorney, the patient experienced an unknown injury.
Additional Manufacturer Narrative
Correction: this was previously reported under mfr report 3005099803-2021-06668.Any new event information will be sent under mfr report 3005099803-2021-06668.Date of event: date of event was approximated to august 15, 2016, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) hospital (b)(6) nedlands wa 6009.Patient code e2401 captures the reportable event of unknown injury.Impact code f12 has been used in the light of the patient sought legal recourse for an unspecified personal injury related to the device.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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 identified, a supplemental medwatch will be filed.

• Brand Name: UPHOLD LITE
• Common Device Name: 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: 15121211
• Report Number: 3005099803-2022-04175
• Device Sequence Number: 20245620
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00003536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female