FDA Adverse Event
Other
Summary report: N
FASTX STERNAL INTRAOSSEOUS DEVICE
MDR report key: 1914472
·
Received November 30, 2010
Report
- Report Number
- 9615387-2010-00016
- Event Type
- Other
- Date Received
- November 30, 2010
- Date of Event
- November 5, 2010
- Report Date
- November 30, 2010
- Manufacturer
- PYNG MEDICAL CORP.
- Product Code
- FMI
- PMA / PMN Number
- K100124
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A RECALL NOTICE WAS SUBMITTED TO THE (B)(6) REGARDING THIS INCIDENT AND MANUFACTURER REPORT #9615387-2010-00012 AND 9615387-2010-00013. FURTHER INVESTIGATION CONTINUES.
Description of Event or Problem · 1
INSERTION DIFFICULTY. DURING A MEDICAL INTERVENTION/ TREATMENT A HEALTH CARE PROFESSIONAL ATTEMPTED TO DEPLOY THE FASTX STERNAL INTRAOSSEOUS DEVICE INTO A PATIENT. THE OPERATOR WAS UNABLE TO PUSH THE HANDLE OF THE DEVICE DOWN COMPLETELY AND, THUS, WAS UNABLE TO GET AN INSERTION. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FASTX STERNAL INTRAOSSEOUS DEVICE | FMI | PYNG MEDICAL CORP. | FASTX-H | 20100609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |