MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068505000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Depression (2361); Dyspareunia (4505)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the obtryx sling fixed on the right side of her vagina.The patient has experienced pain in the right groin, stomach, vagina, rectum, leg, and right foot.The patient indicated being unable to walk for too long or drive long distances.The patient alleged the constant pain prevented her from joining a new job, and from having a normal life.It was stated that the short, painful nights, the isolation from her children and family, and inability to maintain sexual intercourse has led to depression.No actions were reported to be taken in a healthcare facility to address the symptoms.
Additional Manufacturer Narrative
Block h6: patient code e1405 captures the reportable event of painful intercourse.Patient code of e2330 captures the reportable event of pain.Impact code f1202 captures the reportable event of inability to maintain sexual intercourse has led to depression.

• Brand Name: OBTRYX SYSTEM - HALO
• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20481178
• Report Number: 2124215-2024-65211
• Device Sequence Number: 15451318
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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 Model Number: M0068505000
• Device Catalogue Number: 850-500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Other; Required Intervention
• Patient Sex: Unknown