FDA Adverse Event
Malfunction
Summary report: N
PAINSMART IOD
MDR report key: 3237395
·
Received July 9, 2013
Report
- Report Number
- 1722139-2013-02428
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- January 1, 2009
- Report Date
- June 23, 2009
- Manufacturer
- MOOG MEDICAL DEVICE GRP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RECALIBRATED THE VOLUMETRIC AND RESOLVED THE ISSUE.
Description of Event or Problem · 1
INFO RECEIVED STATES THAT VOLUMETRIC INFUSION WAS HIGH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312073 | PAINSMART IOD | FRN | MOOG MEDICAL DEVICE GRP | PAINSMART IOD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |