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); Appropriate Term/Code Not Available (3191)

Patient Problem Genital Bleeding (4507)

Event Date 09/02/2022

Event Type  Injury  

Event Description

On (b)(6) 2022: desara one sis implanted, cystoscopy confirmed no surgical injury.Subject discharged on following day with catheter that was used for 5 days post-op.Event reported as granulation tissue at apex causing bleeding with an unknown start date is noted to have resolved with minor/intra-office surgical intervention on (b)(6) 2022.Ae was determined by investigator to be: moderate; not related to desara one device; not to sling implant procedure; definitely related to concomitant procedure: hysterectomy.

• 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
• MDR Report Key: 15745063
• MDR Text Key: 303174815
• Report Number: 3003990090-2022-01547
• 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

• Date FDA Received: 11/07/2022
• 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: M06038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization; Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic