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 Codes	Inflammation (1932); Pain (1994)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if surgeon will do corrective surgeries.She also did not mention putting any of the patients on pain medications.The lot history record has been reviewed and did not show any non-conformances or deviations related to the issue.The implant is not available for investigation.Based upon the details presented, it is unknown if the complaint as described is a result of the device, surgical procedure, or patient history.The potential for adverse reactions such as infection, inflammation, foreign body response are known events and are listed in the product ifu #10-139-04 in the adverse reactions and contraindications sections.
Event or Problem Description
Surgeon had 3 (three) patients who had a significant pain reaction in the mons area.They have a lot of inflammation, tenderness with firm reaction tissue in the retropubic space.It does not look infected.The surgeon and sales representative have been contacted for further information.This submission is mdr 2 of the 3 reported adverse events.

• Brand Name: DESARA BLUE TV
• Common Device Name: PELVIC MESH SLING
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills, ca
• MDR Report Key: 9779398
• Report Number: 3003990090-2020-01497
• Device Sequence Number: 2456571
• 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): 03/02/2020

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: 08/28/2022
• Device Catalogue Number: CAL-DS01BTV
• Device Lot Number: K08032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/03/2020
• 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