FDA Adverse Event
Other
Summary report: N
FLEXTEND 2 IS-1 BI POSITIVE FIX RA/RV 52 CM
MDR report key: 1451770
·
Received August 7, 2009
Report
- Report Number
- 2124215-2009-11708
- Event Type
- Other
- Date Received
- August 7, 2009
- Date of Event
- March 10, 2009
- Report Date
- August 7, 2009
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND 2 IS-1 BI POSITIVE FIX RA/RV 52 CM | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4096 | NA |