FDA Adverse Event
Malfunction
Summary report: N
TUBE, GASTROINTESTINAL (AND ACCESS)
MDR report key: 1070331
·
Received June 27, 2008
Report
- Report Number
- 3006260740-2008-00023
- Event Type
- Malfunction
- Date Received
- June 27, 2008
- Date of Event
- May 23, 2008
- Report Date
- June 3, 2008
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- KNT
- PMA / PMN Number
- K033562
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.
Description of Event or Problem · 1
THE DEVICE CAME OUT OF THE PATIENT'S BODY 8 DAYS AFTER PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TUBE, GASTROINTESTINAL (AND ACCESS) | KNT | C. R. BARD INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |