MAUDE Adverse Event Report: CALDERA MEDICAL; DESARA BLUE

Catalog Number CAL-DS01B

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

Patient Problems Incontinence (1928); Urinary Incontinence (4572)

Event Date 06/20/2022

Event Type  Injury  

Event Description

On (b)(6) 2022: desara blue tor implanted, cystoscopy confirmed no surgical injury.Subject discharged on the following day without issue.Subject reported worsening urge incontinence from (b)(6) 2022.Ae was determined by investigator to be: mild; not related to desara blue device; possibly to sling implant procedure; not related to concomitant procedure.It was recommended to subject that she use "timed voiding" to address and event is considered resolved.

• Type of Device: DESARA BLUE
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL
• Manufacturer Contact: ryan troncoso ; 4360 park terrace drive
• MDR Report Key: 15745054
• MDR Text Key: 303175339
• Report Number: 3003990090-2022-01542
• 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

• 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: L03018
• 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 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: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White