FDA.reportPublic FDA data

MAUDE MDR 4039995

MDR report key
4039995
Report number
3004962788-2014-00043
Event key
0
Event type
3
Date of event
2014-07-22
Date received
2014-08-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SHARON MURPHY
Address
161 CHESHIRE LANE NORTH SUITE 100 MINNEAPOLIS MN 55441 US
Phone
203-203-2034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUPERTRAX TRIPLE NEEDLE TIPPED CYTOLOGY BRUSHBRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)SUPERDIMENSION INC.BTGSDTNB1500SDTNB1500Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-08-1901. H; 2. O

Event Narratives#

N

Patient 1

A COMPONENT OF TE SUPERDIMENSION SYSTEM; CASE RECORDINGS, WERE RETURNED AND EVALUATED. THE EVALUATION RESULTED IN NO PROBLEM FOUND. THE ISSUE WAS NOT VERIFIED IN LAB; THEREFORE, NO CONCLUSION COULD BE MADE. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE SYSTEM CONSOLE. THE LOT NUMBER FOR THE TRIPLE NEEDLE CYTOLOGY BRUSH WAS NOT PROVIDED BY THE SITE THEREFORE NO INTERNAL REVIEW WAS CONDUCTED. IF ADD'L INFO IS REC'D A F/U REPORT WILL BE SUBMITTED. PNEUMOTHORAX IS A KNOWN SHORT TERM COMPLICATION WHEN A LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY.

D

Patient 1

THE PATIENT SUFFERED A PNEUMOTHORAX DURING A SUPERDIMENSION PROCEDURE. THE PATIENT REC'D A CHEST TUBE AND WAS HOSPITALIZED. IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

N

Patient 1