MAUDE Adverse Event Report: CALDERA MEDICAL DESARA ONE

Model Number CAL-DS2111

Device Problem Insufficient Information (3190)

Patient Problem Erosion (1750)

Event Date 11/05/2021

Event Type  Injury  

Manufacturer Narrative

Patient had a desara one sling implanted by an unknown physician, at an unknown location and time.Patient, from (b)(6), to have the implant removed because of pain / discomfort.Dr (b)(6) mentioned the sling was tight and rolled but did not elaborate or give additional details.Based on the information provided and presented, it is unknown whether the issue described is related to the device, patient medical history, or surgical technique(s).

Event Description

Patient was experiencing pain from a desara one implant and had the sling removed.

• Brand Name: DESARA ONE
• Type of Device: DESARA ONE
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer Contact: alicia heckathorne ; 4360 park terrace drive; westlake village, CA 91361 ; 8184837626
• MDR Report Key: 14275093
• MDR Text Key: 290707183
• Report Number: 3003990090-2021-01534
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 00890594000964
• UDI-Public: 00890594000964
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CAL-DS2111
• Device Catalogue Number: CAL-DS2113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2022
• 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