FDA Adverse Event
Other
Summary report: N
CONTOUR THREAD
MDR report key: 975248
·
Received January 3, 2008
Report
- Report Number
- 2522801-2007-00012
- Event Type
- Other
- Date Received
- January 3, 2008
- Date of Event
- March 9, 2006
- Report Date
- January 2, 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
PATIENT REPORTING PROBLEM WOULD NOT SUPPLY HER PHYSICIAN'S NAME TO SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH), THEREFORE, WE WERE NOT ABLE TO VERIFY THE TRAINING OF THE PHYSICIAN OR CHECK THE DEVICE HISTORY RECORDS FOR THE PRODUCT USED ON THIS PATIENT.
Description of Event or Problem · 1
PT REPORTED EXPERIENCING PAIN, INFECTION, BAD SCARRING AND COMPLICATIONS SECONDARY TO SUPERFICIAL PLACEMENT OF PRODUCT. NOT ABLE TO VERIFY ANY OF THE ABOVE WITH INSERTING PHYSICIAN AS THE PT DOES NOT WISH TO SUPPLY THAT INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR THREAD | CONTOUR THREAD | GAW | SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |