MAUDE Adverse Event Report: CALDERA MEDICAL, INC. DESARA BLUE TV; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE

Model Number	CAL-DS01BTV
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Upon opening the product to prepare for surgery, the end of the introducer was found to be cracked.The product never came into contact with the patient and was off the field prior to patient being in the room.New sling was opened to use for the case.

• Brand Name: DESARA BLUE TV
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): CALDERA MEDICAL, INC.; 5171 clareton drive; agoura hills CA 91301
• MDR Report Key: 10482298
• Report Number: 10482298
• Device Sequence Number: 3974764
• Product Code: OTN
• UDI-Device Identifier: 00890594000858
• UDI-Public: 00890594000858
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2020
• Report Date (Section F): 07/30/2020

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
• Operator of Device: No Information
• Device Model Number: CAL-DS01BTV
• Device Catalogue Number: CAL-DS01BTV
• Device Lot Number: K08032
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/30/2020