FDA.reportPublic FDA data

MAUDE MDR 1036638

MDR report key
1036638
Report number
1825146-2008-00018
Event key
0
Event type
3
Date received
2008-05-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
TAMMY BACON
Address
1100 WEST MORGAN ST. SPENCER IN 47460 US
Phone
812-812-8128
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TAO BRUSH I.U.M.C ENDOMETRIAL SAMPLERTAO BRUSHCOOK UROLOGICAL, INC.HHKNAJ-ES-090500U1586825NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-05-0101. O

Event Narratives#

D

Patient 1

CUSTOMER STATES: "THE BALL TIP OF THE TAO BRUSH HAD COME OFF INSIDE THE PATIENT'S UTERUS, AND THEY KNEW THE TIP WAS ON THE BRUSH PRIOR TO PLACEMENT."

N

Patient 1

ONE SPECIMEN JAR CONTAINING THE BRUSH PORTION IN FLUID AND THE BRUSH SHAFT WAS RECEIVED. THE CLEAR SHEATH ON THE SHAFT WAS NOTED TO BE SLID UP 3CM FROM THE HANDLE IN THE OPEN POSITION. THE CLEAR SHEATH WAS ALSO NOTED TO BE SEPARATED INTO TWO SEGMENTS WITH THE POINT OF SEPARATION TO HAVE A TWISTED APPEARANCE. THE SHAFT SEGMENT MEASURED 19.4CM AND THE BRUSH SEGMENT MEASURED 2.9CM. THE WIRES WERE NOTED TO BE CUT BELOW THE BRISTLES OF THE BRUSH; CUT MARKS WERE VISIBLE ON THE WIRES ON BOTH SEGMENTS. CUTTING THE BRUSH OFF FOLLOWING THE PROCEDURE IS COMMON PRACTICE. UPON CLOSE EXAMINATION OF THE DISTAL END, WHERE THE BALL TIP WAS LOCATED, ADHESIVE WAS PRESENT. THE DISTRIBUTOR INDICATED THE PHYSICIAN AND PATIENT AGREED TO NOT REMOVE THE BALL AT THE TIME OF THE SEPARATION; THE PHYSICIAN INDICATED THE PHYSICIAN AND PATIENT AGREED TO NOT REMOVE THE BALL AT THE TIME OF THE SEPARATION; THE PHYSICIAN INDICATED THE BALL SHOULD COME OUT ON IT'S OWN. THE BALL TIP IS MADE OF POLYTHENE PLASTIC AND IS APPROXIMATELY 3MM IN DIAMETER. THE DISTRIBUTOR HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION AND HAS INDICATED THEY HAVE NOT BEEN MADE AWARE AS TO WHETHER THE PATIENT HAS PASSED THE BALL TIP OR NOT. THEY ALSO INDICATED THAT THEY WERE NOT GETTING ANY ADDITIONAL INFORMATION FROM THE PHYSICIAN. EACH BRUSH HAS THE BALL TIP 100% PULL TESTED DURING THE MANUFACTURING PHASE TO ASSURE THE BALL IS SECURE PRIOR TO PACKAGING. WE ARE UNABLE TO DETERMINE WHAT HAS CAUSED THE BALL TO SEPARATE FROM THE SHAFT OF THE BRUSH. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE FORWARDED.