MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON Y MESH KIT; GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES

Model Number	72912
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Incontinence (1928); Pain (1994); Constipation (3274); Dyspareunia (4505); Insufficient Information (4580)
Date of Event	07/22/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; therefore, a failure 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 a upsylon y-mesh implant and a advantage implant were implanted into the patient on (b)(6) 2009.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep; back pain; vaginal pain; pelvic pain; pain inter; inab inter; diff bowel; rec incont.Surgical interventions: on (b)(6) 2009 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: surgery on (b)(6) 2009 was to remove the mesh which had dislodged and this surgery (b)(6) 2009 was to put a new one in.Nonsurgical treatments: on (b)(6) 2015 the patient commenced pain medication: paracetamol for the treatment of: to relieve discomfort.Treatment duration: ongoing.The patient was treated with topical treatment (including oestrogen cream): vagifem for the treatment of: to thicken the vaginal walls and to assist with the painful intercourse.Treatment duration: ongoing.
Additional Manufacturer Narrative
Correction: b5, h6 patient, impact codes.Block a1: (b)(4).Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.Block h6: evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device is not available for return; therefore, a failure 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
Note: two boston scientific mesh devices were implanted into the same patient.This report pertains to the upsylon y-mesh.It was reported to boston scientific corporation that an upsylon y-mesh and an advantage sling were implanted into the patient on (b)(6) 2009.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; painful intercourse; inability to have intercourse; difficulties with bowel motions; recurrent incontinence.Surgical interventions: on (b)(6) 2009 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: surgery on (b)(6) 2009 was to remove the mesh which had dislodged and this surgery (b)(6) 2009 was to put a new one in.Nonsurgical treatments: on (b)(6) 2015 the patient commenced pain medication: paracetamol for purpose: to relieve discomfort.Treatment duration: ongoing.The patient was treated with topical treatment (including oestrogen cream): vagifem for purpose: to thicken the vaginal walls and to assist with the painful intercourse.Treatment duration: ongoing.

• Brand Name: UPSYLON Y MESH KIT
• Common Device Name: GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12931143
• Report Number: 3005099803-2021-07304
• Device Sequence Number: 14653252
• Product Code: OHD
• UDI-Device Identifier: 08714729848103
• UDI-Public: 08714729848103
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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: 72912
• Device Catalogue Number: 72912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/05/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 55 KG