FDA Adverse Event
Death
Summary report: N
SCD TUBING
MDR report key: 1725517
·
Received June 11, 2010
Report
- Report Number
- 9612030-2010-00017
- Event Type
- Death
- Date Received
- June 11, 2010
- Report Date
- June 1, 2010
- Manufacturer
- COVIDIEN
- Product Code
- JOW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON 06/01/2010 THAT A CUSTOMER HAD AN ISSUE WITH A PAIR OF SCD TUBING. THE CUSTOMER REPORTS APPROXIMATELY 2 YEARS AGO AT A PREVIOUS FACILITY, A PATIENT FELL AND HIT HER HEAD AFTER GETTING ENTANGLED IN THE SCD CORDS. FIVE DAYS LATER, THE PATIENT PASSED AWAY OF A SUBDURAL HEMATOMA. SPOKE WITH (B) (4) ON 06/09/2010. (B) (4) STATED THAT SHE WAS UNSURE IF THE PAST FACILITY SHE WORKED AT EVEN USED COVIDIEN SCD EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCD TUBING | SCD TUBING | JOW | COVIDIEN | UNK VT | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |