FDA Adverse Event
Injury
Summary report: N
ONE STEP BUTTON INITIAL PLACEMENT KIT
MDR report key: 1015107
·
Received March 12, 2008
Report
- Report Number
- 3005099803-2008-00261
- Event Type
- Injury
- Date Received
- March 12, 2008
- Report Date
- February 11, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORP
- Product Code
- KNT
- PMA / PMN Number
- K910584
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. THE JANUARY 2007 15-MONTH ONE STEP BUTTON - ENTERAL FEEDING PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE STEP BUTTON INITIAL PLACEMENT KIT | KGC | KNT | BOSTON SCIENTIFIC CORP | M00563030 | 9785179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |