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); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 05/10/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 - desara blue tor implanted, cystoscopy confirmed normal/no surgical injury.Subject discharged same day, though unable to void before discharge.Subject was sent home with indwelling catheter.(pelvic) pain is recorded as an ae.Event started on same day as sling implant, (b)(6) 2022 and is considered ongoing, recovering/resolving.Subject was given pain medication to treat: percocet prn from (b)(6) 2022 and tylenol prn from (b)(6) 2022 - ongoing.Ae was determined by investigator to be: mild; not related to desara blue device; not related to sling implant procedure; possibly related to concomitant procedure: pelvic organ prolapse repair.

• Brand Name: DESARA BLUE
• Type of Device: DESARA BLUE
• 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: 15745057
• MDR Text Key: 303174878
• Report Number: 3003990090-2022-01546
• 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: 11/07/2022

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 Catalogue Number: CAL-DS01B
• Device Lot Number: M07002
• 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: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian