FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3240168
·
Received July 22, 2013
Report
- Report Number
- 2124215-2013-10875
- Event Type
- Injury
- Date Received
- July 22, 2013
- Date of Event
- June 5, 2013
- Report Date
- June 5, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS INVOLVED IN INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION BUT WERE UNSUCCESSFUL. ALL AVAILABLE INFORMATION SUGGESTS THAT THE PRODUCT REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339617 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0286 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Hospitalization| L| R | 0286| 4469| T125| E110| E162| 6944 |