FDA Adverse Event
Other
Summary report: N
ON-Q PAIN PUMP
MDR report key: 1872286
·
Received September 8, 2010
Report
- Report Number
- 2026095-2010-00138
- Event Type
- Other
- Date Received
- September 8, 2010
- Date of Event
- January 4, 2008
- Report Date
- December 28, 2009
- Manufacturer
- I-FLOW CORP.
- Product Code
- MEB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WAS RECEIVED FROM THE FDA, MEDWATCH (B)(4). AS NO CUSTOMER INFO WAS PROVIDED, NO FURTHER INFO COULD BE OBTAINED. WITHOUT THE CONTACT INFO, ACTUAL PRODUCT, LOT, OR SPECIFIC EVENT INFO, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND THE LOT HISTORY CANNOT BE REVIEWED.
Description of Event or Problem · 1
MEDWATCH INDICATED INJURY THAT REQUIRED INTERVENTION TO THE SHOULDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ON-Q PAIN PUMP | ELASTOMERIC PUMP | MEB | I-FLOW CORP. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |