FDA Adverse Event
Injury
Summary report: N
TUBE, GASTROINTESTINAL (AND ACCESS)
MDR report key: 1022012
·
Received March 31, 2008
Report
- Report Number
- 2523003-2008-00022
- Event Type
- Injury
- Date Received
- March 31, 2008
- Date of Event
- February 26, 2008
- Report Date
- March 6, 2008
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- KNT
- PMA / PMN Number
- K915841
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.
Description of Event or Problem · 1
A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. THE INDWELLING PERIOD WAS 287 DAYS. THE DOME PORTION WAS REMOVED IMMEDIATELY.
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 |