MAUDE Adverse Event Report: CALDERA MEDICAL Desara One; DESARA ONE SIS

Model Number CAL-DS2113

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); Uterine Perforation (2121)

Event Date 08/30/2022

Event Type  Injury  

Event Description

On (b)(6) 2022: desara one sis implanted.Cystoscopy confirmed mesh in bladder.Repair of urethra and placement of sling was required (revision/resurgery) to address perforation of urethra (injury by surgeon not with trocar) at time of sling implant procedure.Symptoms of mesh exposure confirmed to be resolved at time of revision.Dates of urethra perforation (right lateral): on (b)(6) 2022 ae was determined by investigator to be: moderate, not related to desara one device, definitely to sling implant procedure, not related to concomitant procedure.

• Brand Name: Desara One
• Type of Device: DESARA ONE SIS
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer Contact: ryan troncoso ; 4360 park terrace drive; westlake village, CA 91361
• MDR Report Key: 15745359
• MDR Text Key: 303180590
• Report Number: 3003990090-2022-01543
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 00890594000971
• UDI-Public: 00890594000971
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CAL-DS2113
• Device Catalogue Number: CAL-DS2113
• Device Lot Number: N04028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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): Other; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White