FDA Adverse Event
Other
Summary report: N
25X1 MAGELLAN SAFETY NEEDLE
MDR report key: 1490659
·
Received September 28, 2009
Report
- Report Number
- 1017768-2009-00131
- Event Type
- Other
- Date Received
- September 28, 2009
- Date of Event
- September 16, 2009
- Report Date
- September 21, 2009
- Manufacturer
- COVIDIEN
- Product Code
- FMI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON 09/21/2009, THAT A CUSTOMER HAD AN ADVERSE EVENT WHILE USING OUR PRODUCT. CUSTOMER REPORTS THE CARE GIVER GAVE THE SHOT TO THE PEDIATRIC PATIENT, THEN TRIED TO DO A SURFACE ACTIVATION OF THE MAGELLAN SAFETY NEEDLE AND STUCK THE MOTHER WHO WAS HELPING TO HOLD THE CHILD. THE PRODUCT DID NOT MALFUNCTION; THE CUSTOMER IS ACCUSTOMED TO OTHER ACTIVATION METHODS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 25X1 MAGELLAN SAFETY NEEDLE | SAFETY NEEDLE | FMI | COVIDIEN | 8881850510 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |