MAUDE Adverse Event Report: CALDERA MEDICAL, INC DESARA; SURGICAL MESH

Model Number CAL-DS01

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994)

Event Type  Injury  

Event Description

Event has reported to caldera medical by fda.Complaint sates that the doctor at the hospital implanted a "tension free vaginal tapping" mesh through the retropubic space into my body for urinary stress incontinence into my body.This mesh sling is manufactured by caldera medical, catalog number cal ds01, lot #12003, expiration date: 01/01/2014.Nine months later, i started having pain in the area of the implant, in the groin, and a couple months later, a tingling numbness sensation in the rectal area which gradually worsened.I also felt something that felt like a wire inside of my vagina which was mesh erosion.In 2012, the doctor did a partial mesh removal.In 2013, the doctor did a second partial removal (leaving the arms).My pain is not much better, and i hurt down on my right leg into my foot.I went to the doctor in 2013 for a consultation and am scheduled for my third mesh removal surgery in 2014.

• Brand Name: DESARA
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): CALDERA MEDICAL, INC; 5171 clateton drive; agoura hills CA 91301
• Manufacturer Contact: vicki gail ; 5171 clareton drive; agoura hills, CA 91301-4523 ; 8188796555
• MDR Report Key: 4300516
• MDR Text Key: 21331273
• Report Number: 3003990090-2014-00003
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/23/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2014
• Device Model Number: CAL-DS01
• Device Catalogue Number: CAL-DS01
• Device Lot Number: 12003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention