MAUDE Adverse Event Report: VERTOS MEDICAL INC. VERTOS MILD DEVICE KIT

Model Number MDK-0001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Paresis (1998); Discharge (2225)

Event Date 10/07/2020

Event Type  Injury  

Event Description

A mild procedure was performed on the patient on (b)(6) 2020.An epidurogram was administered, and the patient was treated bilaterally.No issues arose during the case.On 10/23/2020, the physician reported to a company representative that the patient had experienced oozing from the treatment site, and issues with lower limb functionality 7-10 days post procedure.The patient was admitted to the hospital, and a lumbar decompression was performed to treat an apparent epidural hematoma.At the time the incident was reported, the patient's lower limb issues had not subsided.No further information has been reported, as the patient is no longer in contact with the treating physician.

• Brand Name: VERTOS MILD DEVICE KIT
• Type of Device: MILD DEVICE KIT
• Manufacturer (Section D): VERTOS MEDICAL INC.; 95 enterprise,ste 325; aliso viejo CA 92656
• Manufacturer (Section G): VERTOS MEDICAL INC; 95 enterprise ste 325; aliso viejo CA 92656
• Manufacturer Contact: troy williams ; 95 enterprise ste 95; aliso viejo, CA 92656 ; 9494274720
• MDR Report Key: 10855005
• MDR Text Key: 216717157
• Report Number: 3006450448-2020-00002
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: B235MDK00010
• UDI-Public: B235MDK00010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

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: Health Professional
• Device Model Number: MDK-0001
• Device Catalogue Number: MDK-0001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: No
• 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