MAUDE Adverse Event Report: CALDERA MEDICAL DESARA ONE

Model Number CAL-DS2113

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Incontinence (1928)

Event Date 10/15/2022

Event Type  Injury  

Event Description

On (b)(6) 2022: desara one sis implanted, cystoscopy confirmed no surgical injury.Subject discharged on the following day without issue.Subject reporting de novo urge incontinence as of on (b)(6) 2022.Event is currently ongoing.Urinalysis and urine culture have been obtained.Ae was determined by investigator to be: mild, possibly related to desara one device, possibly to sling implant procedure, not related to concomitant procedure.

• Brand Name: DESARA ONE
• Type of Device: 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 91361
• MDR Report Key: 15745702
• MDR Text Key: 303220722
• Report Number: 3003990090-2022-01544
• 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: 11/07/2022

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: N06014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2022
• 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): Other; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White