FDA Adverse Event
Injury
Summary report: N
V. MUELLER
MDR report key: 5057990
·
Received August 31, 2015
Report
- Report Number
- MW5055958
- Event Type
- Injury
- Date Received
- August 31, 2015
- Date of Event
- August 19, 2015
- Report Date
- August 31, 2015
- Manufacturer
- CAREFUSION
- Product Code
- OCV
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
A MICRO DISSECTOR TIP BROKE OFF IN SIDE THE SURGICAL SITE. DOCTOR WAS ABLE TO LOCATE AND REMOVE THE BROKEN TIP. THE TIP AND THE INSTRUMENT WERE IMMEDIATELY REMOVED FROM THE STERILE FIELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 575982 | V. MUELLER | V. MUELLER | OCV | CAREFUSION | NL 3785-010 | AIO | |
| 575983 | RHOTON HOOK 90 BLUNT | RHOTON HOOK 90 BLUNT | GZX | INTEGRA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |