MAUDE Adverse Event Report: CALDERA MEDICAL DESARA BLUE OV

Catalog Number CAL-DS01BOV

Device Problems Defective Component (2292); Material Split, Cut or Torn (4008)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2022

Event Type  malfunction  

Event Description

Desara blue tore during mid-urethral sling on (b)(6) 2022.Per surgeon, mesh "felt that it could have been caught on something.Patient bmi is 43 and had no history of retropubic procedures".

• Brand Name: DESARA BLUE OV
• Type of Device: DESARA BLUE OV
• 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: 16486523
• MDR Text Key: 310855437
• Report Number: 3003990090-2022-01548
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00890594000681
• UDI-Public: 00890594000681
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/02/2023

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?: Yes
• Device Catalogue Number: CAL-DS01BOV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 03/06/2023
• 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
• Patient Sex: Female