MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONSERVIA; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068504210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Dysuria (2684); Constipation (3274)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a conservia sling device was implanted into the patient during a procedure performed on (b)(6) 2017.The patient had to have a hysterectomy and was advised to undergo placement of small transobturator tape for small urinary leaks.After the implantation, from (b)(6), 2017, the patient had experienced some postoperative complications.The mesh had to be severed due to urinary retention.She had subsequent urinary tract infection, pain in the urethra, vaginal area, buttocks, thigh and a terminal constipation.Currently, the patient still has difficulty in urinating and urinary tract infections.Pain is also present in the vagina, urethra, buttocks and thighs, especially when sitting and squatting, and in the lower back.
Additional Manufacturer Narrative
The exact patient age is unknown; however the patient was born in (b)(6).This event was reported by the patient.The healthcare facility name is unknown but reported to be in (b)(6).Report source (other): ansm materiovigilance report number (b)(4), submitted to ansm (french competent authority) by the patient.(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.

• Brand Name: CONSERVIA
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: 13664846
• Report Number: 3005099803-2022-01037
• Device Sequence Number: 17511586
• Product Code: OTN
• UDI-Device Identifier: 08714729856030
• UDI-Public: 08714729856030
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2022

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: 09/14/2018
• Device Model Number: M0068504210
• Device Catalogue Number: 73225
• Device Lot Number: PD00005628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 50 KG