FDA Adverse Event
Injury
Summary report: N
MEDEX CLEAR-CUFF PRESSURE INFUSOR
MDR report key: 1673410
·
Received April 23, 2010
Report
- Report Number
- 2183502-2010-00153
- Event Type
- Injury
- Date Received
- April 23, 2010
- Report Date
- April 19, 2010
- Manufacturer
- SMITHS MEDICAL ASD, INC
- Product Code
- KZD
- PMA / PMN Number
- EXEMPT CLASS
- Report Source
- Manufacturer report
- 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 IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL. (B) (4).
Description of Event or Problem · 1
.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDEX CLEAR-CUFF PRESSURE INFUSOR | KZD - INFUSOR, PRESSURE, FOR I.V. BAGS | KZD | SMITHS MEDICAL ASD, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |