FDA.reportPublic FDA data

MAUDE MDR 487948

MDR report key
487948
Report number
1226348-2003-00230
Event key
0
Event type
3
Date of event
2003-07-22
Date received
2003-10-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MATTHEW KING
Address
325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
Phone
508-508-5088
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CODMAN DISPOSABLE VEIN STRIPPERSTRIPPER, VEIN, DISPOSABLECODMAN & SHURTLEFF, INC.GAJNA63-4031CV512NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-10-0801. R

Event Narratives#

D

Patient 1

INTERNATIONAL AFFILIATE REPORTS THE PT HAD A VEIN STRIPPED IN JULY 2003. THE PROCEDURE WENT WELL AND THE VEINS WERE REMOVED AND WOUNDS WERE SUTURED CLOSED. THE PT COMPLAINED OF A LUMP IN THE LEG. THE PT WAS ADMITTED IN SEPTEMBER 2003 AND THE FORIEGN BODY WAS REMOVED. THE FOREIGN BODY WAS THE SMALL OLIVE WHICH WAS ATTACHED ONTO THE STRIPPER CABLE. THE OLIVE HAD APPARENTLY SEPARATED FROM THE CABLE DURING THE ORIGINAL VEIN STRIPPING PROCEDURE. NO PRODUCT IS BEING RETURNED FOR EVALUATION.