FDA Adverse Event
Death
Summary report: N
ACUCISE RP 35, ACU-PACK
MDR report key: 263414
·
Received February 18, 2000
Report
- Report Number
- 2027111-2000-00002
- Event Type
- Death
- Date Received
- February 18, 2000
- Report Date
- February 18, 2000
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- KOD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A ROUTINE SALES CALL TO DR, TERRITORY MANAGER WAS TOLD BY DR THAT A COLLEAGUE OF DR USED AN B1005 ACUCISE CATHETER ON A PT. THE PT ACCORDING TO DR WAS FINE IMMEDIATELY AFTER THE PROCEDURE BUT EXPERIENCED ARTERIAL BLEEDING ABOUT SEVEN DAYS LATER AND DIED. MULTIPLE ATTEMPTS HAVE BEEN MADE BY APPLIED MEDICAL'S PRODUCT MANAGER TO CONTACT DR TO OBTAIN INFO OF THE EVENT. NO CALLS HAVE BEEN RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUCISE RP 35, ACU-PACK | ACUCISE CATHETER | KOD | APPLIED MEDICAL RESOURCES | B1005 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |