FDA Adverse Event
Summary report: N
ON-Q¿ PAINBUSTER¿ POST-OP PAIN RELIEF SYSTEM
MDR report key: 2850027
·
Received November 26, 2012
Report
- Report Number
- 2850027
- Date Received
- November 26, 2012
- Date of Event
- November 3, 2012
- Report Date
- November 26, 2012
- Manufacturer
- KIMBERLY CLARK
- Product Code
- MEB
- Report Source
- User Facility report
- Reporter Location
- VA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
STATUS POST LEFT LOWER LOBE WEDGE RESECTION, ONQ PAIN PUMP SYSTEM;THE NEXT DAY PATIENT RETIRED THAT EVENING WITHOUT INCIDENT, WOKE WITH WEAKNESS IN EXTREMITIES; AND SEEN THE NEXT DAY (TWO DAYS POST PROCEDURE) BY NEUROLOGIST AND ANESTHESIOLOGIST, ONQ DISCONTINUED AS IT WAS FELT SHE WAS EXPERIENCING A SPREAD OF HER LOCAL ANESTHESIA. SYMPTOMS DID SUBSIDE AND PATIENT WAS DISCHARGED TWO DAYS AFTER ONQ WAS DISCONTINUED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ON-Q¿ PAINBUSTER¿ POST-OP PAIN RELIEF SYSTEM | PUMP, INFUSION, ELASTOMERIC | MEB | KIMBERLY CLARK | CB004 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | NONE KNOWN| NO OTHER THERAPIES |