FDA Adverse Event
Malfunction
Summary report: N
DGW .035 FC J3MM 150CM TEF
MDR report key: 459776
·
Received May 9, 2003
Report
- Report Number
- 1016427-2002-00176
- Event Type
- Malfunction
- Date Received
- May 9, 2003
- Report Date
- October 1, 2002
- Manufacturer
- CORDIS CORPORATION (MIAMI)
- Product Code
- MKI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE PRODUCT COATING WAS DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DGW .035 FC J3MM 150CM TEF | CARDIOLOGY WIRES & METALS | MKI | CORDIS CORPORATION (MIAMI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |