MAUDE Adverse Event Report: CALDERA MEDICAL; DESARA BLUE

Catalog Number CAL-DS01B

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 07/01/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 - desara blue tor implanted, cystoscopy confirmed normal/no surgical injury.Subject discharged same day without issue.Subject reports ae of occasional urgency beginning sometime in (b)(6) (post-procedure) and this is still ongoing, though recovering/resolving without treatment.Ae was determined by investigator to be: mild; not related to desara blue device; possibly related to sling implant procedure; not related to concomitant procedure.

• Type of Device: DESARA BLUE
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer Contact: ryan troncoso
• MDR Report Key: 15745067
• MDR Text Key: 303174926
• Report Number: 3003990090-2022-01541
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00089059400650
• UDI-Public: 0089059400650
• 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 Catalogue Number: CAL-DS01B
• Device Lot Number: N03009
• 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: 03/09/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White