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

Model Number	CAL-DS01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	10/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based upon the details as provided, it can be concluded that the issue as described is not the result of the caldera medical devices, but rather a non-caldera medical device (mandrin).The cm product performed to specification and intended use.It is unknown of the issue resulted due to surgical procedure or patient history.
Event or Problem Description
Sales rep reported bladder perforation caused by a mandrin (non-caldera instrument) during implantation of a desara sling.He states that the surgeon already pulled the sling through the suprapubic incisions and tensioned before suturing the bladder.After the incident, the surgeon could not find the sling in the center incision anymore.Surgeon stated that the patient's tissue must have been too weak to support it.It took him about 10 minutes to find the sling and remove it from the patient.Clarification with the surgeon and sales rep revealed that a mandrin (non-caldera instrument), used for catheterization, punctured the bladder during surgery.

• Brand Name: DESARA
• Common Device Name: PELVIC MESH
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• MDR Report Key: 6995258
• Report Number: 3003990090-2017-01430
• Device Sequence Number: 1184453
• Product Code: OTN
• UDI-Device Identifier: 00890594000629
• UDI-Public: 00890594000629
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: CAL-DS01
• Device Catalogue Number: CAL-DS01
• Device Lot Number: H03013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/01/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization