FDA Adverse Event
Injury
Summary report: N
HWDV0028-30#HEMASHIELD PLATINUM WOVEN
MDR report key: 6503560
·
Received April 19, 2017
Report
- Report Number
- 2242352-2017-00391
- Event Type
- Injury
- Date Received
- April 19, 2017
- Date of Event
- December 29, 2016
- Report Date
- April 19, 2017
- Manufacturer
- MAQUET SAS
- Product Code
- MAL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MAQUET CARDIOVASCULAR FILES AS THE IMPORTER FOR THIS DEVICE. INTERVASCULAR SAS IS RESPONSIBLE FOR MANUFACTURER REPORTING.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THEY FOUND A ASPERGILLUS FUNGAL INFECTION IN THE HEMASHIELD PLATINUM WOVEN GRAFT WHICH HAD BEEN IMPLANTED IN THE PATIENT (B)(6) 2016 AND HAD TO BE EXPLANTED (B)(6) 2017. AN EDWARDS PRODUCT WAS IMPLANTED AND EXPLANTED ALONG WITH THE HEMASHIELD GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287299 | HWDV0028-30#HEMASHIELD PLATINUM WOVEN | GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE | MAL | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |