FDA Adverse Event
Injury
Summary report: N
ON-Q PAIN RELIEF SYSTEM
MDR report key: 6830703
·
Received August 30, 2017
Report
- Report Number
- MW5071852
- Event Type
- Injury
- Date Received
- August 30, 2017
- Date of Event
- August 27, 2017
- Report Date
- August 27, 2017
- Manufacturer
- AVENT
- Product Code
- MEB
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ROPIVACAINE 0.2% WAS ADMINISTERED VIA ON-Q PUMP TO SCIATIC NERVE AFTER PODIATRY SURGERY. ON LEFT FOOT. I DEVELOPED URINARY INCONTINENCE AND HAD TO WEAR ADULT DIAPERS. ON SECOND DAY, I REMOVED THE ON-Q PUMP. I REPORTED TO ANESTHESIOLOGIST ON CALL BECAUSE OF SEVERE INCONTINENCE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 609707 | ON-Q PAIN RELIEF SYSTEM | ON-Q PAIN PUMP | MEB | AVENT | 0202688597 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |