MAUDE Adverse Event Report: CALDERA MEDICAL DESARA ONE; SURGICAL MESH

Catalog Number CAL-DS2113

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2020

Event Type  Injury  

Event Description

During the second pass of the procedure, the surgeon was unable to deploy the introducer, and the sling was removed.The procedure was completed with a new device.No other information has been provided.The device was not returned for investigation.It is unknown whether the event was due to the device, surgical procedure, patient anatomy or other circumstances.

• Brand Name: DESARA ONE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer Contact: alicia heckathorne ; 4360 park terrace drive; westlake village, CA 91361 ; 8188796555
• MDR Report Key: 14274833
• MDR Text Key: 290667381
• Report Number: 3003990090-2021-01529
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CAL-DS2113
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female