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MAUDE MDR 20555

MDR report key
20555
Report number
20555
Event key
0
Event type
3
Date of event
1994-05-09
Date received
1995-03-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHEMO-SITEPORTA-CATHDEVICE LABSLLDPRODUCT # 3502979306YY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11995-03-0101. H; 2. R

Event Narratives#

D

Patient 1

68 YO PATIENT HAD IMPLANTATION OF A CHEMOPORT AS ANGIOACCESS FOR IV CHEMOTHERAPY IN FEBRUARY, 94. FUNCTIONING WELL UNTIL RECENTLY WHEN IRRIGATION PRODUCED SUBCUTANEOUS SWELLING BELOW LEFT CLAVICLE. CONTRAST STUDIES THROUGH PORT SHOWED TWO SEPARATE AREAS OF EXTRAVASATION. TO OR FOR REVISION OF PORT; CATHETER FOUND TO BE SHEARED OFF 5/20/94 REMOVAL OF SHEARED OFF PORTION OF CATHETER