FDA Adverse Event
Injury
Summary report: N
ABBOTT
MDR report key: 494830
·
Received November 7, 2003
Report
- Report Number
- MW4003612
- Event Type
- Injury
- Date Received
- November 7, 2003
- Date of Event
- January 16, 2003
- Report Date
- October 27, 2003
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
POST CHEST TUBE INSERTION ON MORPHINE PCA FOR PAIN RELIEF. PT BECAME VERY SEDATED AND DIFFICULT TO AROUSE. BASAL RATE HAD ALREADY BEEN DISCONTINUED DURING NIGHT. NARCAN 0.1MG GIVEN. PT AROUSABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT | APM II PUMP | FRN | ABBOTT LABORATORIES | APM II | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | MORPHINE SULFATE MANUFACTURED BY ABBOTT. |