FDA Adverse Event
Other
Summary report: N
CONTOUR THREAD
MDR report key: 952443
·
Received November 8, 2007
Report
- Report Number
- 2522801-2007-00011
- Event Type
- Other
- Date Received
- November 8, 2007
- Manufacturer
- SURGICAL SPECIALTIES CORP./ANGIOTECH
- Product Code
- GAW
- PMA / PMN Number
- K050548
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE GORE-TEX WAS USED WITH THE CT400 CONTOUR THREADS. THE GORE-TEX IS NOT MANUFACTURED BY SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH). THE GORE-TEX PLEDGET COULD BE USED IN CONJUNCTION WITH THE CONTOUR THREAD.
Description of Event or Problem · 1
PT HAD A CONTOUR THREAD PROCEDURE IN 2006 AND HAS HAD FREQUENT PROBLEMS WITH GORE-TEX EXTRUSION. PT REQUIRED SURGICAL INTERVENTION TO REMOVE GORTEX THAT HAD BEEN EXTRUDING FROM INSERTION SITES. PT HAD CHRONIC INFECTION AT INSERTION SITES WHICH REQUIRED THREE COURSES OF ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR THREAD | CONTOUR THREAD | GAW | SURGICAL SPECIALTIES CORP./ANGIOTECH | CT400 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |