FDA Adverse Event
Injury
Summary report: N
WALLFLEX ENTERAL COLONIC STENT
MDR report key: 970539
·
Received December 28, 2007
Report
- Report Number
- 6000050-2007-00167
- Event Type
- Injury
- Date Received
- December 28, 2007
- Date of Event
- November 29, 2007
- Report Date
- November 29, 2007
- Manufacturer
- BOSTON SCIENTIFIC IRELAND, LTD.
- Product Code
- MQR
- PMA / PMN Number
- K000281
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REMAINS IMPLANTED; THEREFORE, A DEVICE EVALUATION CANNOT BE PERFORMED. THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT IS UNDETERMINED. THE OCTOBER 2007 15-MONTH WALLFLEX ENTERAL STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES WAS REVIEWED; NO ADVERSE TREND WAS NOTED.
Description of Event or Problem · 1
NOTE: THIS REPORT ADDRESSES THE SECOND OF THREE RELATED DEVICES (REFER TO MANUFACTURER REPORT #6000050-2007-00163 FOR THE EVENT DETAILS AND ALSO REFER TO MANUFACTURER REPORT #6000050-2007-00166 FOR THE THIRD DEVICE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WALLFLEX ENTERAL COLONIC STENT | MQR | BOSTON SCIENTIFIC IRELAND, LTD. | M00565040 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |