FDA Adverse Event
Malfunction
Summary report: N
REPLACEMENT TUBE
MDR report key: 2020574
·
Received February 10, 2011
Report
- Report Number
- 1527460-2011-00010
- Event Type
- Malfunction
- Date Received
- February 10, 2011
- Date of Event
- December 17, 2010
- Report Date
- January 20, 2011
- Manufacturer
- ABBOTT NUTRITION
- Product Code
- KNT
- PMA / PMN Number
- K861323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED A BALLOON BURST. THE TUBE WAS IN PLACE FOR TWO WEEKS, AND THE BALLOON BURST ON (B)(6), 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLACEMENT TUBE | KNT, TUBES GASTROINTESTINAL AND ACCESSORIES | KNT | ABBOTT NUTRITION | 51364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |