FDA Adverse Event
Malfunction
Summary report: N
ACCUSURE
MDR report key: 1530980
·
Received November 13, 2009
Report
- Report Number
- 1039144-2009-00025
- Event Type
- Malfunction
- Date Received
- November 13, 2009
- Report Date
- November 12, 2009
- Manufacturer
- SHIN CHANG MEDICAL CO., LTD.
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
CONSUMER STATED THAT ON SEVERAL OCCASIONS WHILE USING THE SYRINGES, THE SYRINGES BROKE OFF AND REMAINED STUCK IN THE SKIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCUSURE | INSULIN SYRINGE | FMF | SHIN CHANG MEDICAL CO., LTD. | 0603-6999-21 | SD0310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |