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 |