MAUDE Adverse Event Report: CALDERA MEDICAL INC. DESARA BLUE TV; PELVIC MESH

Catalog Number	CAL-DS01BTV
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The risk of bladder/organ perforation is a known potential adverse event and is listed in the adverse reactions section of the desara blue tv product ifu #10-139-06.When cmi devices are used as directed per the product ifu and intended use, the benefit to the patient for the treatment of stress urinary incontinence outweighs this risk.
Event or Problem Description
The surgeon perforated the bladder to the extent where mesh entered the bladder, the sling had to be removed and the procedure could not be completed.Surgeon suspected that he may not have displaced the bladder far enough with a catheter to avoid perforating the bladder with the instrument.

• Brand Name: DESARA BLUE TV
• Common Device Name: PELVIC MESH
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hill, ca
• MDR Report Key: 10460409
• Report Number: 3003990090-2020-01505
• Device Sequence Number: 13993232
• Product Code: OTN
• UDI-Device Identifier: 00890594000834
• UDI-Public: 00890594000834
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: No Information
• Device Expiration Date: 12/04/2022
• Device Catalogue Number: CAL-DS01BTV
• Device Lot Number: K12002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization