FDA Adverse Event
Injury
Summary report: N
CLEO 90 INFUSION SET
MDR report key: 1033323
·
Received April 23, 2008
Report
- Report Number
- 2183502-2008-00102
- Event Type
- Injury
- Date Received
- April 23, 2008
- Date of Event
- March 21, 2008
- Report Date
- April 22, 2008
- Manufacturer
- SMITHS MEDICAL MD, (FORMERLY DELTEC, INC)
- Product Code
- FPA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. WHEN AND IF DEVICE BECOMES AVAILABLE, AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
INFO WAS RECEIVED THAT REPORTED A PT WAS TREATED FOR INFECTION. REPORTEDLY, THE PT RECEIVED TOPICAL ANTIBIOTICS FROM HIS ENDOCRINOLOGIST TO TREAT A LOCALIZED INFECTION AT THE PT'S INSULIN SET INFUSION SITE. IT WAS REPORTED THAT THE PT ONLY USES HIS ABDOMEN FOR HIS SITES, CHANGES EVERY THREE DAYS, AND ALSO HAS TWIDDLER'S SYNDROME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLEO 90 INFUSION SET | SUBCUTANEOUS INFUSION SET | FPA | SMITHS MEDICAL MD, (FORMERLY DELTEC, INC) | 21-7220 | 003X78 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Required Intervention |