MAUDE Adverse Event Report: CALDERA MEDICAL, INC. DESARA BLUE SHORT SUTURE SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP

Model Number	CAL-DS01BS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The string broke.

• Brand Name: DESARA BLUE SHORT SUTURE SLING
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP
• Manufacturer (Section D): CALDERA MEDICAL, INC.; 4360 park terrace drive; westlake village CA 91361
• MDR Report Key: 18967478
• Report Number: 18967478
• Device Sequence Number: 6479276
• Product Code: OTO
• UDI-Device Identifier: 00890594000735
• UDI-Public: (01)00890594000735
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/18/2024
• Report Date (Section F): 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CAL-DS01BS
• Device Lot Number: P07018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/18/2024