MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION JPLASMA

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 11/14/2019

Event Type  Injury  

Event Description

Patient had liposuction of abdomen, flanks, medial and lateral things and arms followed by reunion.Patient had air build up that caused swelling in the neck and face areas.

• Brand Name: JPLASMA
• Type of Device: JPLASMA
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: april baures ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7278038554
• MDR Report Key: 9436661
• MDR Text Key: 170480498
• Report Number: 3007593903-2019-00032
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR