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

Model Number CAL-DS01BTV

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2020

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 205299086
• Report Number: 10482298
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00890594000858
• UDI-Public: 00890594000858
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2020,07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CAL-DS01BTV
• Device Catalogue Number: CAL-DS01BTV
• Device Lot Number: K08032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2020
• Device Age: 1 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1