MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPLANT MESH UPSYLON Y SYN; GYNECOLOGICAL LAPAROACOPIC KIT

Model Number 831-820

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fainting (1847); Unspecified Infection (1930); Sepsis (2067); Weakness (2145); Peritonitis (2252); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 12/31/2018

Event Type  Injury  

Event Description

Sudden onset of severe abdominal pain.Pain started at 1:15pm, went to the emergency room (er) around 3:00pm ct.Scan of abdominal pelvis demonstrates high suspicion for cecal volvulus, very weak and faint in triage.White count normal.Post op diagnosis: cecal volvulus caused by suture or mesh from bladder lift procedure.Strangulation of cecum and proximal right colon and terminal ileum.Gangrenous right colon cecum and terminal ileum, abdominal peritonitis, abdominal sepsis and infection from gangrenous cecum and right colon.This was by far the worst night of my life.I just turned 60 and i¿m extremely fit and active with all aspects of my life.

• Brand Name: IMPLANT MESH UPSYLON Y SYN
• Type of Device: GYNECOLOGICAL LAPAROACOPIC KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8310513
• MDR Text Key: 135743856
• Report Number: MW5083714
• Device Sequence Number: 1
• Product Code: OHD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/28/2008
• Device Model Number: 831-820
• Device Lot Number: C002445
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 60 YR
• Patient Weight: 52