FDA Adverse Event
Malfunction
Summary report: N
CURLIN INFUSION PAINSMART IOD IV PUMP
MDR report key: 2272911
·
Received September 7, 2011
Report
- Report Number
- 1722139-2011-00316
- Event Type
- Malfunction
- Date Received
- September 7, 2011
- Date of Event
- June 22, 2010
- Report Date
- August 10, 2011
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Removal / Correction Number
- Z-1870-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PAINSMART IOD IV PUMP (B)(4) IS UNDER RECALL (B)(4).
Description of Event or Problem · 1
INFO RECEIVED INDICATES PUMP EXPERIENCED ERROR CODE 45.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN INFUSION PAINSMART IOD IV PUMP | FRN | MOOG MEDICAL DEVICES GROUP | PAINSMART IOD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |