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

Model Number	CAL-VLY2643
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot history record for the implant, lot # h08002 was reviewed for any issues which may have contributed to the product complaint.There are no associated waivers, deviations, non-conformances, or corrective/preventive actions associated with this lot during the manufacturing process.The product was not returned to the site and no further information has been received.Based upon the details presented, it is unclear if the complaint as described is a result of the device, surgical procedure, or patient history.Although there are known risks associated with the use of caldera medical's mesh products, these risks are noted in the warnings/adverse reaction section of each product's instructions for use (ifu).
Event or Problem Description
Patient underwent her first surgery for laparoscopic supracervical hysterectomy, removal of both tubes and ovaries, laparoscopic sacrolpopexy, 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.Uf/importer report # (b)(4).

• Brand Name: VERTESSA LITE Y-MESH
• Common Device Name: POP MESH
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills, ca
• Manufacturer (Section G): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills, ca
• Manufacturer Contact: ieva sirokoviene ; 5171 clareton drive; agoura hills, ca ; 4837641
• MDR Report Key: 7419882
• Report Number: 3003990090-2018-01440
• Device Sequence Number: 16923216
• Product Code: OTO
• UDI-Device Identifier: 00890594000469
• UDI-Public: 00890594000469
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2022
• Device Model Number: CAL-VLY2643
• Device Catalogue Number: CAL-VLY2643
• Device Lot Number: H08002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 04/10/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2017
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Female