FDA Adverse Event
Injury
Summary report: N
NONE
MDR report key: 1401247
·
Received June 9, 2009
Report
- Report Number
- 3003910212-2009-00016
- Event Type
- Injury
- Date Received
- June 9, 2009
- Date of Event
- April 17, 2009
- Report Date
- June 8, 2009
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- HWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 1
GORE WAS NOTIFIED IN 2009 OF AN EVENT INVOLVING A GORE SUTURE PASSER DEVICE. NO SPECIFIC INFO WAS RECEIVED AT THAT TIME. ON 05/21/2009 GORE RECEIVED INFO AND BECAME AWARE THE GORE SUTURE PASSER NEEDLE BROKE OFF DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, AND REMAINS IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | NONE | HWQ | W.L. GORE & ASSOCIATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |