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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UPTAKE MEDICAL CORP. INTERVAPOR SYSTEM, GENERATOR

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UPTAKE MEDICAL CORP. INTERVAPOR SYSTEM, GENERATOR Back to Search Results
Model Number UM-GEN-100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hemoptysis (1887); Unspecified Infection (1930); Pneumonia (2011); Respiratory Distress (2045); Chronic Obstructive Pulmonary Disease (COPD) (2237); Cancer (3262)
Event Date 11/06/2012
Event Type  Death  
Event Description
Report of pt death 55 days post intervapor treatment.Interevapor treatment occurred on (b)(6) 2012 and pt was discharged 5 days later.Several weeks after the intervapor treatment, pt was admitted with a copd exacerbation.During that admission, it was identified that the pt had bladder cancer.The pt was transferred to another hospital and had surgical treatment for the cancer.On (b)(6) 2012, pt admitted with dyspnea and massive hemoptysis with infection.The family elected morphine care and declined further treatment with the pt dying the following day.Pt expired due to infectious exacerbation/pneumonia.Comorbidity history of recent surgery of bladder cancer within two weeks of hospital admittance.
 
Manufacturer Narrative
This mdr is being reported retrospectively.However, a manufacturer's incident report was filed with bfarm on (b)(4) 2012 (ref.Report # (b)(4)) and a field safety corrective action report was filed on (b)(4) 2012 (ref.(b)(4)) as the product was marketed in europe.(b)(4).
 
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Brand Name
INTERVAPOR SYSTEM, GENERATOR
Type of Device
INTERVAPOR SYSTEM, GENERATOR
Manufacturer (Section D)
UPTAKE MEDICAL CORP.
tustin CA
Manufacturer Contact
1173 warner ave
tustin, CA 92780
9494911377
MDR Report Key4039927
MDR Text Key4903183
Report Number3009385324-2014-00003
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 08/18/2014
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 Expiration Date04/27/2017
Device Model NumberUM-GEN-100
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/14/2012
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/08/2012
Initial Date FDA Received08/19/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
ONGOING SUPPLEMENTAL OXYGEN; SURGICAL TREATMENT FOR BLADDER CANCER
Patient Outcome(s) Death;
Patient Age63 YR
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