MAUDE Adverse Event Report: CALDERA MEDICAL, INC. VERTESSA LITE Y-MESH; MESH, SURGICAL

Model Number CAL-VLY2643A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Nausea (1970)

Event Date 02/06/2018

Event Type  malfunction  

Event Description

Patient underwent her first surgery for laparoscopic supracervical hysterectomy, removal of both tubes and ovaries, laparoscopic sacrocolpopexy, anterior and posterior repair, and cystoscopy.Patient was admitted five days later with nausea and abdominal pain.Subsequently, nine days later the patient underwent surgery for diagnostic laparoscopy, lysis of adhesion, open laparotomy, and partial small bowel resection with anastomosis.The y-mesh was adhering to the bowel in right lower quadrant of abdomen.

• Brand Name: VERTESSA LITE Y-MESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): CALDERA MEDICAL, INC.; 5171 clareton dr; agoura hills CA 91301
• MDR Report Key: 7373110
• MDR Text Key: 103551359
• Report Number: 7373110
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2018,03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/10/2022
• Device Model Number: CAL-VLY2643A
• Device Catalogue Number: CAL-VLY2643A
• Device Lot Number: H08002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR