FDA Adverse Event
Injury
Summary report: N
CLEO 90 INFUSION SET
MDR report key: 3143378
·
Received May 24, 2013
Report
- Report Number
- 2183502-2013-00250
- Event Type
- Injury
- Date Received
- May 24, 2013
- Report Date
- May 22, 2013
- Manufacturer
- SMITHS MEDICAL
- Product Code
- FPA
- PMA / PMN Number
- K042172
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE INVESTIGATION.
Description of Event or Problem · 1
DEVICE WAS IN USE WITH HOME CARE PT. ACCORDING TO THE REPORTER, THE PT HAD AN ABSCESS AT THE DEVICE INFUSION SITE AFTER 14 DAYS USE. ACCORDING TO THE REPORTER, THE PT REPORTED TO HER LOCAL CLINIC AND ABSCESS WAS DRAINED AND PT WAS PRESCRIBED A 14 DAY COURSE ANTIBIOTICS. NO PERMANENT ADVERSE EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231091 | CLEO 90 INFUSION SET | FPA - SUBCUTANEOUS INFUSION SET | FPA | SMITHS MEDICAL | 21-7232 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |