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); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Constipation (3274); Dyspareunia (4505); Insufficient Information (4580)
Date of Event	01/01/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a upsylon y-mesh was implanted into the patient on an unspecified date.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; thigh pain; other pain: lower stomach pain and legs; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; damage.Nonsurgical treatments: on (b)(6) 2015 the patient commenced other medication (please specify): ural for the treatment of: uti's.Treatment duration: as needed.On (b)(6) 2019 the patient commenced pain medication: panadol/ibuprofen for the treatment of: pain relief, as needed.Treatment duration: 2 years.On (b)(6) 2020 the patient commenced pain medication: panadeine forte for the treatment of: pain relief, as needed.Treatment duration: 1 year.On (b)(6) 2021 the patient commenced topical treatment (including oestrogen cream): voltarin for the treatment of: pain relief.Treatment duration: 6 months.
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.
Additional Manufacturer Narrative
Block a1: (b)(6).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 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.Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2020-06762.
Event or Problem Description
It was reported to boston scientific corporation that a upsylon y-mesh was implanted into the patient on an unspecified date.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; thigh pain; other pain: lower stomach pain and legs; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; damage.Nonsurgical treatments: on (b)(6) 2015 the patient commenced other medication (please specify): ural for the treatment of: uti's.Treatment duration: as needed.On (b)(6) 2019 the patient commenced pain medication: panadol/ibuprofen for the treatment of: pain relief, as needed.Treatment duration: 2 years.On (b)(6) 2020 the patient commenced pain medication: panadeine forte for the treatment of: pain relief, as needed.Treatment duration: 1 year.On (b)(6) the patient commenced topical treatment (including oestrogen cream): voltarin for the treatment of: pain relief.Treatment duration: 6 months.

• 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 morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12931128
• Report Number: 3005099803-2021-07235
• Device Sequence Number: 4802555
• 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
• 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): 01/28/2022

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 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: 01/07/2022
• Initial Report FDA Received Date: 12/05/2021
• Supplement Report FDA Received Date: 01/28/2022
• 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: 41 YR
• Patient Sex: Female