FDA Adverse Event Other Summary report: N

EVLT KITS

MDR report key: 907421 · Received September 4, 2007

Report

Report Number
9617149-2007-00002
Event Type
Other
Date Received
September 4, 2007
Report Date
March 27, 2007
Manufacturer
DIOMED, LTD.
Product Code
GEX
PMA / PMN Number
K041957
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

PHYSICIAN COMPLETED THREE SEPARATE EVLT CASES ON THREE DIFFERENT PATIENTS AND IN ALL THREE CASES THE PHYSICIAN FEELS THE PATIENTS MAY HAVE RECEIVED SMALL BURNS ON THE OUTSIDE OF THE SKIN RESULTING IN MINOR BLISTERS. PATIENT #1 - AREA TREATED RIGHT GSV; ENTRY SITE WAS MID TO UPPER CALF; LENGTH TREATED 56CM; COMPRESSION DRESSINGS - (3) 4X4S ROLLED OVERTOP THE LENGTH OF THE VESSEL, COBAN WRAP WITH COMPRESSION HOSE OVERTOP. PHYSICIAN DIAGNOSIS GRADE 2 BURNS, TREAT WAS NEOSPORIN AND STERILE 4X4S. PATIENT FOLLOW-UP IN 2007. PATIENT #2 - AREA TREATED RIGHT LSV ALONG WITH RIGHT ANTERIOR THIGH SCLEROTHERAPY. ENTRY SITE WAS JUST BELOW THE MUSCLE OF THE CALF. COMPRESSION DRESSINGS - (3) 4X4S ROLLED OVERTOP THE LENGTH OF THE VESSEL, COBAN WRAP WITH COMPRESSION HOSE OVERTOP. PHYSICIAN DIAGNOSIS GRADE 2 BURNS, TREATMENT WAS NEOSPORIN AND STERILE 4X4S. PATIENT FOLLOW-UP IN 2007. PATIENT #3 - AREA TREATED LEFT GSV; ENTRY SITE AT THE KNEE; LENGTH TREATED 19CM; COMPRESSION DRESSINGS - (3) 4X4S ROLLED OVERTOP WITH ADHESIVE TAP THE LENGTH OF THE VESSEL, AND COMPRESSION STOCKING. PHYSICIAN DIAGNOSIS GRADE 2 BURNS, TREATMENT WAS NEOSPORIN AND STERILE 4X4S. PATIENT FOLLOW-UP IN THE SAME MONTH. ALL PATIENTS WERE FOLLOWED AND DETERMINED TO BE FINE WITH NO ADDITIONAL COMPLICATIONS. PHYSICIAN HAS NOT HAD ANY OTHER PROBLEMS LIKE THIS SINCE. ALL PRODUCTS WERE DISCARDED BY THE PHYSICIAN, BUT PATIENT PICTURES WERE RECEIVED AND REVIEWED BY DIOMED AND ANOTHER INDEPENDENT VASCULAR SURGEON. WHAT THE PHYSICIAN IS CALLING BURNS WE CANNOT CONFIRM OR DENY WITHOUT FURTHER INFORMATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 EVLT KITS EVLT PROCEDURE KITS GEX DIOMED, LTD. UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 YR Required Intervention