FDA Adverse Event
Malfunction
Summary report: N
ENDOVIVE STANDARD PEG KITS PULL METHOD
MDR report key: 1230986
·
Received October 28, 2008
Report
- Report Number
- 3005099803-2008-05532
- Event Type
- Malfunction
- Date Received
- October 28, 2008
- Date of Event
- September 26, 2008
- Report Date
- September 29, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNT
- PMA / PMN Number
- K031538
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO THE COMPLAINANT, THE DEVICE REMAINS IN USE BY THE PT AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD, ORIGINALLY PLACED IN 2008, THE TAB ON THE FEEDING ADAPTER CAP IS "PEELING AWAY AND IS CLOSE TO FALLING OFF." NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED TO BE "FINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOVIVE STANDARD PEG KITS PULL METHOD | KNT | BOSTON SCIENTIFIC CORPORATION | M00568201 | 11485081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |