MAUDE Adverse Event Report: CALDERA MEDICAL DESARA BLUE; SURGICAL SLING

Catalog Number	CAL-DS01B
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
After surgeon perforated the bladder, it was determined the sling would not be implanted and a catheter would be left in overnight.No other treatment was believed to be needed.During the procedure a cal-tv32 was used with a retropubic transvaginal approach.

• Brand Name: DESARA BLUE
• Common Device Name: SURGICAL SLING
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace dr; westlake village CA 91301
• Manufacturer Contact: alicia heckathorne ; 4360 park terrace dr; westlake village 91361 ; 8188798555
• MDR Report Key: 14274623
• Report Number: 3003990090-2021-01530
• Device Sequence Number: 14929402
• Product Code: OTN
• UDI-Device Identifier: 00890594000650
• UDI-Public: 00890594000650
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191416
• 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): 09/21/2021

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 Expiration Date: 08/25/2023
• Device Catalogue Number: CAL-DS01B
• Device Lot Number: L08024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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