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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAVITRON; DENTSPY
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CAVITRON; DENTSPY Back to Search Results
Device Problem Contamination (1120)
Patient Problems Abscess (1690); Unspecified Infection (1930); Tissue Damage (2104)
Event Date 09/04/2015
Event Type  Injury  
Event Description
Cross contamination from ultrasonic teeth cleaning from dentist using the dentsply/cavitron device.During this time i was immunosuppressed due to methotrexate usage from preexisting autoimmune condition.Dentist aware of health history.On (b)(6) 2015, i was admitted to the hospital with a lung abscess, which was treated with iv antibiotics for 3 1/2 weeks.The lung damage from the infection was diagnosed as bronchiectasis due to infection from aspiration, which created cystic bullae disease.On (b)(6) 2016, the bullae created from the infection in my left lung burst, resulting in a collapsed lung.I was admitted to the icu from (b)(6) 2016.The damage to my lung was so severe a left lower lobectomy was necessary to remove the damage tissue.On (b)(6) 2016, i am scheduled to undergo a right lower lobe/bullae resection (possible lobectomy) to prevent further damage to healthy lung tissue and/or spontaneous pneumothorax.I have no prior history of lung disease or infections.Please contact me if you would like more info about this incident and/or to review any medical records.
 
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Brand Name
CAVITRON
Type of Device
DENTSPY
MDR Report Key5719843
MDR Text Key47230026
Report NumberMW5062760
Device Sequence Number1
Product Code ELC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/07/2016
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/08/2016
Type of Device Usage N
Patient Sequence Number1
Treatment
POTASSIUM
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age51 YR
Patient Weight72
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