FDA Adverse Event
Other
Summary report: N
CONTOUR THREAD
MDR report key: 1003516
·
Received February 15, 2008
Report
- Report Number
- 2522801-2008-00004
- Event Type
- Other
- Date Received
- February 15, 2008
- Date of Event
- January 1, 2005
- Report Date
- February 14, 2008
- Manufacturer
- SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
- Product Code
- GAW
- PMA / PMN Number
- K050548
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L 510 K # K042856-BROW LIFT, K050247-NECK LIFT.
Description of Event or Problem · 1
PT HAD A CONTOUR THREAD NECK LIFT PROCEDURE 2 YEARS AGO (2005). PT STATES THAT SINCE THE PROCEDURE SHE HAS HAD CONSTANT PAIN AND DISCOMFORT. PT DESCRIBES IT AS " FEELS LIKE CRUSHED GLASS UNDER MY SKIN." PT BELIEVED THAT THIS WAS A NORMAL FEELING AND THAT IT " WAS ALL PART OF THE RECOVERY." PT STATES BEING SATISFIED WITH THE OVERALL RESULTS OF THE PROCEDURE. HOWEVER, AFTER 2 YEARS WITH NO PAIN RELIEF, PT REVISITED HER PHYSICIAN AND HAD THE THREAD REMOVED. PT STATES THAT HER PHYSICIAN WAS NOT ABLE TO REMOVE ALL THE THREADS BUT BELIEVES THAT HE RETRIEVED AT LEAST 75 % OF THE PRODUCT. (THIS HAS NOT BEEN VERIFIED BY THE PHYSICIAN AS PER THE PT.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR THREAD | BARBED THREAD AND NEEDLE | GAW | SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |