FDA Adverse Event
Injury
Summary report: N
WALLSTENT ENTERAL ENDOPROSTHESIS
MDR report key: 1062915
·
Received June 19, 2008
Report
- Report Number
- 3005099803-2008-00804
- Event Type
- Injury
- Date Received
- June 19, 2008
- Report Date
- May 21, 2008
- Manufacturer
- BOSTON SCIENTIFIC IRELAND, LTD
- Product Code
- MQR
- PMA / PMN Number
- K000281
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE MANUFACTURE DATE IS UNK SINCE THE UPN AND LOT NUMBER WERE NOT ASCERTAINABLE FROM THE COMPLAINANT. THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.
Description of Event or Problem · 1
NOTE: THE DATE OF EVENT IS UNK. DURING A PRESENTATION AT THE 2008 DIGESTIVE DISEASE WEEK CONFERENCE, DATA WAS PRESENTED ON THE STUDY. A HEMOBILIA EVENT, WHICH INVOLVED A WALL STENT ENTERAL ENDOPROSTHESIS DEVICE, OCCURRED IN A PT. NO ADDITIONAL INFO WAS PROVIDED REGARDING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WALLSTENT ENTERAL ENDOPROSTHESIS | MQR | BOSTON SCIENTIFIC IRELAND, LTD | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |