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

Catalog Number CAL-DS01

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Dyspareunia (4505)

Event Type  Injury  

Manufacturer Narrative

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 acute and/or chronic pain (including groin pain), and dyspareunia are known events and are listed in the product ifu adverse reactions and contraindications sections.

Event Description

On (b)(6) 2011 patient underwent transobturator mid-urethral sling (cal-ds01) insertion, and patient was experiencing lif/groin pain and dyspareunia since surgery.On (b)(6) 2020 desara sling was explanted.

• Brand Name: DESARA
• Type of Device: PELVIC MESH SLING
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• Manufacturer (Section G): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• Manufacturer Contact: ieva sirokoviene ; 5171 clareton drive; agoura hills, CA 91301 ; 8184837641
• MDR Report Key: 10844199
• MDR Text Key: 216379553
• Report Number: 3003990090-2020-01521
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 11/16/2020

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
• Device Operator: No Information
• Device Catalogue Number: CAL-DS01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention