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

Model Number CAL-DS01TV

Device Problem Insufficient Information (3190)

Patient Problem Internal Organ Perforation (1987)

Event Type  Injury  

Manufacturer Narrative

No further information has been received.A phone call with the surgeon will be scheduled to obtain more information.

Event Description

When providing feedback on a caldera medical product, the surgeon stated that he and his fellows have experienced bladder perforation in the past during teaching using desara tv.The surgeon and sales rep report that the patient was "fine and had no problems'.More information as to this past event is being obtained.Product has not been returned and lot numbers are not available.N further information has been received.

Manufacturer Narrative

A phone call with the surgeon was held on (b)(6) 2018 for further clarification.During this call, the surgeon stated that the dilator tube aperture (where instrument is inserted), seems to create a rigid fold that could potentially cause tissue trauma if the bladder were to be punctured.However, he states that he feels it is not clinically significant and is not sharp enough to cause injury.Additionally, he stated that in his experience, all patients have been okay after this occurs.No further information regarding lot numbers and dates related to the adverse event has been reported.

Event Description

When providing feedback on a caldera medical product, the surgeon stated that he and his fellows have experienced bladder perforation in the past during teaching using desara tv.The surgeon and sales rep report that the patient was "fine and had no problems'.More information as to this past event is being obtained.Product has not been returned and lot numbers are not available.No further information has been received.

• Brand Name: DESARA TV
• Type of Device: PELVIC MESH
• 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: vicki gail ; 5171 clareton drive; agoura hills, CA 91301 ; 8188796555
• MDR Report Key: 7148295
• MDR Text Key: 95835823
• Report Number: 3003990090-2017-01431
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

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: Physician
• Device Model Number: CAL-DS01TV
• Device Catalogue Number: CAL-DS01TV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization