MAUDE Adverse Event Report: CALDERA MEDICAL DESARA ONE

Model Number	CAL-DS2113
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022: desara one sis implanted, cystoscopy confirmed no surgical injury.Subject discharged on same day without issue.Subject reported event of tailbone pain on (b)(6) 2022 (same day as procedure).Pain was treated with tylenol and aleve.Event is considered resolved without sequelae.Ae was determined by investigator to be: moderate, not related to desara one device, not to sling implant procedure, definitely related to concomitant procedure: pelvic organ prolapse repair.

• Brand Name: DESARA ONE
• Common Device Name: DESARA ONE
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer Contact: ryan troncoso ; 4360 park terrace drive; westlake village, CA 91631
• MDR Report Key: 15745303
• Report Number: 3003990090-2022-01545
• Device Sequence Number: 12538130
• Product Code: PAH
• UDI-Device Identifier: 00890594000971
• UDI-Public: 00890594000971
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2022

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
• Device Model Number: CAL-DS2113
• Device Catalogue Number: CAL-DS2113
• Device Lot Number: N06006
• 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: 11/07/2022
• 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: Other; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White