FDA Adverse Event
Malfunction
Summary report: N
RELION 1CC INS SYR 31X5/16
MDR report key: 1080558
·
Received July 17, 2008
Report
- Report Number
- 1915484-2008-00039
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Date of Event
- June 20, 2008
- Report Date
- June 24, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 07/16/2008. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH AND INSULIN SYRINGE. THE CUSTOMER REPORTS HE TAKES 8 SHOTS A DAY OF PAIN MEDICINE (NOT INSULIN) AND THE CANNULAS ARE BREAKING OFF IN HIS SKIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RELION 1CC INS SYR 31X5/16 | INSULIN SYRINGE | FMF | TYCO HEALTHCARE/KENDALL | 8881608040 | 817600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |