FDA Adverse Event
Injury
Summary report: N
WALLFLEX ENTERAL COLONIC STENT
MDR report key: 1012953
·
Received March 13, 2008
Report
- Report Number
- 3005099803-2008-00266
- Event Type
- Injury
- Date Received
- March 13, 2008
- Report Date
- February 13, 2008
- Manufacturer
- BOSTON SCIENTIFIC IRELAND, LTD
- Product Code
- MQR
- PMA / PMN Number
- K042065
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT STATED THAT THE LOT NUMBER IS UNK; THEREFORE, THE MFR DATE IS UNK. THE DEVICE REMAINS IMPLANTED; THEREFORE, A DEVICE EVAL CANNOT BE PERFORMED. THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT IS UNDETERMINED. THE 2008 15-MONTH WALLFLEX ENTERAL STENT PROD FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.
Description of Event or Problem · 1
NOTES: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2008-00265 FOR EVENT DETAILS. THE DATE OF EVENT IS UNK; HOWEVER, THE PERFORATION OCCURRED SOMETIME IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WALLFLEX ENTERAL COLONIC STENT | MQR | BOSTON SCIENTIFIC IRELAND, LTD | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |