MAUDE Adverse Event Report: CALDERA MEDICAL DESARA TVEZ 30; DS01BTV30

Model Number	CAL-DS01BTV30
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Bladder perforation using desara tvez.

• Brand Name: DESARA TVEZ 30
• Common Device Name: DS01BTV30
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361 5696
• Manufacturer (Section G): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91631 5696
• Manufacturer Contact: ryan troncoso ; 4360 park terrace drive; westlake village, CA 91631-5696
• MDR Report Key: 15135882
• Report Number: 3003990090-2022-01537
• Device Sequence Number: 5307990
• Product Code: OTN
• UDI-Device Identifier: 00890594000124
• UDI-Public: 00890594000124
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: CAL-DS01BTV30
• Device Catalogue Number: DS01BTV30
• Device Lot Number: N05042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female