FDA Adverse Event Injury Summary report: N

HEAMSHIELD WOVEN DOUBLE VELOUR GRAFT

MDR report key: 84215 · Received April 14, 1997

Report

Report Number
2242352-1997-00026
Event Type
Injury
Date Received
April 14, 1997
Report Date
March 18, 1997
Manufacturer
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
Product Code
MAL
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

PT DEVELOPED FEVER AFTER IMPLANTATION OF GRAFT. NOTE: A REQUEST FOR ADD'L INFO WAS SENT TO THE DR ON 3/19/97. NO ADD'L INFO HAS BEEN FORTHCOMING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HEAMSHIELD WOVEN DOUBLE VELOUR GRAFT Implant SEALED VASCULAR GRAFT MAL MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 166168 196030

Patients

Seq Age Sex Outcome Treatment
1 NO INFO Other