FDA Adverse Event
Malfunction
Summary report: N
FILIFORM
MDR report key: 467353
·
Received June 18, 2003
Report
- Report Number
- 2429473-2003-00064
- Event Type
- Malfunction
- Date Received
- June 18, 2003
- Report Date
- June 5, 2003
- Manufacturer
- RUSCH INC.
- Product Code
- FAX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS DEVICE CRACKED AT METAL PART.
Description of Event or Problem · 1
CUSTOMER REPORTS DEVICE CRACKED AT METAL PART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FILIFORM | UROLOGICAL | FAX | RUSCH INC. | NA | 93535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |