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	Perforation (2001)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Details about the patient are unknown, and 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
During the procedure, the physician was doing the final tensioning on the implant when he noticed one side had perforated the bladder.The physician proceeded to readjust the other side when he notice the bladder was perforated as well.The physician stopped the procedure, did not implant the sling, placed a catheter in the patient.Patient was sent home and will return some time later for the operation.

• Brand Name: DESARA ONE
• Common Device Name: DESARA ONE
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91631
• Manufacturer (Section G): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91631
• Manufacturer Contact: alicia heckathorne ; 4360 park terrace drive; westlake village, CA 91361 ; 8184837626
• MDR Report Key: 14275001
• Report Number: 3003990090-2021-01533
• Device Sequence Number: 5908227
• Product Code: PAH
• UDI-Device Identifier: 00890594000964
• UDI-Public: 00890594000964
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• 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): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• 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