FDA Adverse Event
Death
Summary report: N
UNKNOWN PREFILL
MDR report key: 1339315
·
Received March 6, 2009
Report
- Report Number
- 3002859087-2009-00007
- Event Type
- Death
- Date Received
- March 6, 2009
- Date of Event
- February 1, 2008
- Report Date
- March 2, 2009
- Manufacturer
- COVIDIEN
- Product Code
- NZW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IN 2009, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH HEPARIN. THE ATTORNEY ALLEGES THAT IN 2008, THE DECEDENT WAS ADMITTED TO THE HOSPITAL FOR BACK SURGERY. AS PART OF HIS TREATMENT, HE WAS ADMINISTERED HEPARIN. SUBSEQUENT TO THE ADMINISTRATION OF HEPARIN, THE DECEDENT EXPERIENCED RESPIRATORY DISTRESS, A RAPID DECREASE OF HIS PLATELET COUNT, TACHYCARDIA AND A RAPID DECREASE OF HIS BLOOD PRESSURE. DECEDENT SUFFERED PHYSICAL DAMAGE WHICH ULTIMATELY CAUSED HIS DEATH TWO DAYS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PREFILL | HEPARIN PREFILLED SYRINGE | NZW | COVIDIEN | UNKNOWN PREFILL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |