MAUDE Adverse Event Report: CALDERA MEDICAL DESARA ONE

Model Number	CAL-DS2111
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient was experiencing pain from a desara one implant and had the sling removed.

• Brand Name: DESARA ONE
• Common Device Name: 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
• Report Number: 3003990090-2021-01534
• Device Sequence Number: 17603023
• Product Code: PAH
• UDI-Device Identifier: 00890594000964
• UDI-Public: 00890594000964
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Sex: Female