MAUDE Adverse Event Report: Boston Scientific Corporation CanGaroo Envelope; Implantable Surgical Mesh

Model Number	BC04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury

• Brand Name: CanGaroo Envelope
• Common Device Name: Implantable Surgical Mesh
• Manufacturer (Section D): Boston Scientific Corporation; 1100 old ellis rd; suite 1200; roswell GA 30076
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION BOSTO; 110 old ellis rd suite 1200; roswell GA 30076
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50903010
• Report Number: 2124215-2026-51274
• Device Sequence Number: 16128836
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: (01)00859389005072
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: D583162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: Lay User/Patient
• Device Expiration Date: 04/23/2022
• Device Model Number: BC04
• Device Catalogue Number: BC04
• Device Lot Number: M20A1016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 01/07/2020
• 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; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male