FDA Adverse Event
Injury
Summary report: N
ABBOTT
MDR report key: 356040
·
Received October 12, 2001
Report
- Report Number
- MW4003096
- Event Type
- Injury
- Date Received
- October 12, 2001
- Date of Event
- May 23, 2001
- Report Date
- August 14, 2001
- Manufacturer
- ABBOTT LABS, HOSPITAL PRODUCTS DIVISION
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT UNDERWENT HYSTERECTOMY AND SALPINGO-OOPHORECTOMY. POSTOP ON PCA MORPHINE SULFATE. FOUND UNRESPONSIVE REQ ADVANCED CARDIAC LIFE SUPPORT. GIVEN NARCAN AND TRANSFERRED TO ICU FOR MONITORING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45981 | ABBOTT | PCA PUMP | FRN | ABBOTT LABS, HOSPITAL PRODUCTS DIVISION | * | 01950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Life Threatening |