FDA Adverse Event
Malfunction
Summary report: N
BUTTON REPLACEMENT GASTROSTOMY DEVICE
MDR report key: 1181622
·
Received September 25, 2008
Report
- Report Number
- 3005099803-2008-04843
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- August 27, 2008
- Report Date
- August 28, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNT
- PMA / PMN Number
- K971906
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008, THAT A BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS PLACED THE DAY PRIOR. ACCORDING TO THE COMPLAINANT, DURING PREP, THE OBTURATOR PENETRATED THE BUTTON DOME. REPORTEDLY, ANOTHER BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BUTTON REPLACEMENT GASTROSTOMY DEVICE | KNT | BOSTON SCIENTIFIC CORPORATION | M00568280 | 11469975 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |