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

Catalog Number	CAL-DS01BTV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Erosion (1750)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgeon and rep have been contacted for further information.Dr.(b)(6) couldn't identify specific cause of that could have contributed to the extrusion and the product is not available for investigation.The lot history record for desara blue tv # k06022 shows no non-conformances or deviations that could have caused or contributed to this incident.The product was used prior to its expiration date of 06-20-2022.Based upon the information as presented, it is unknown whether the issue as described is related to the device, patient medical history, or surgical technique.Mesh erosion/exposure/explant is a known risk with the use of all mesh procedures and may be due to device malfunction, surgical procedure, or patient medical history.
Event or Problem Description
Sales rep reported that dr.(b)(6) patient experienced an extrusion using desara blue tv.Surgeon just sutured up the extrusion and is hoping that will solve the problem.The patient was not experiencing any pain or discomfort, although dr.(b)(6) is concerned she may experience painful intercourse.He is going to continue to monitor her and if necessary he will cut out the piece of mesh that is extruding.

• Brand Name: DESARA BLUE TV
• Common Device Name: PELVIC MESH SLING
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• MDR Report Key: 9419630
• Report Number: 3003990090-2019-01491
• Device Sequence Number: 484666
• Product Code: OTN
• UDI-Device Identifier: 00890594000834
• UDI-Public: 00890594000834
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K1326069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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 Expiration Date: 06/20/2022
• Device Catalogue Number: CAL-DS01BTV
• Device Lot Number: K06022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/05/2019
• 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; Required Intervention