FDA Adverse Event
Injury
Summary report: N
PREMIUM SURGICLIP S-9.0 TITANIUM
MDR report key: 2103026
·
Received May 9, 2011
Report
- Report Number
- 2647580-2011-00312
- Event Type
- Injury
- Date Received
- May 9, 2011
- Date of Event
- March 30, 2011
- Report Date
- April 18, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- FZP
- PMA / PMN Number
- K853650
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: DURING THE CASE, THE DEVICE DELIVERS AN INACCURATE CLIP AND HAS TO BE REMOVED AND/OR REPLACED. THE MAMMARY ARTERY WAS CUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREMIUM SURGICLIP S-9.0 TITANIUM | DISPOSABLE CLIP APPLIER | FZP | USSC PUERTO RICO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |