FDA Adverse Event
Injury
Summary report: N
GORE SUTURE PASSER
MDR report key: 1060889
·
Received June 13, 2008
Report
- Report Number
- 3003910212-2008-00014
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 16, 2008
- Report Date
- June 13, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES,INC
- Product Code
- HWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 1
IT WAS REPORTED TO GORE THE TIP OF GORE SUTURE PASSER NEEDLE BROKE OFF IN THE FASCIA OF A PT. THE PHYSICIAN DID NOT ATTEMPT REMOVAL AND IT REMAINS IN THE PT. THE PT REMAINS ASYMPTOMATIC. NO DEVICE IS AVAILABLE FOR EXAMINATION. FURTHER INVESTIGATION IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE SUTURE PASSER | NONE | HWQ | W.L. GORE & ASSOCIATES,INC | WLG105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |