FDA Adverse Event
Malfunction
Summary report: N
T.E.D.
MDR report key: 2496525
·
Received March 16, 2012
Report
- Report Number
- 1017072-2012-00003
- Event Type
- Malfunction
- Date Received
- March 16, 2012
- Report Date
- March 5, 2012
- Manufacturer
- COVIDIEN
- Product Code
- DWL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(6) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A ANTI-EMBOLISM STOCKING. THE CUSTOMER REPORTS THE PT WAS SUBMITTED TO NEURO SURGERY BECAUSE SHE HAS A MENINGEAL TUMOR. THE SURGERY TOOK APPROX 9 HOURS COUNTING TIME OF ANESTHESIA INDUCTION. AS PROPHYLAXIS, ANTI-EMBOLISM STOCKINGS AND INTERMITTENT PNEUMATIC COMPRESSION SYSTEM WERE USED. THE PT WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE UNIT, POST-OPERATIVE THE PT INFERRED INABILITY OF THE LEFT FOOT MOVEMENT, THE PT IS ASSESSED BY THE TREATING PHYSICIAN WHO REPORTS A POSSIBLE NEUROPRAXIA OF THE PERONEAL NERVE OR POPLITEAL SCIATIC LEFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | T.E.D. | ANTI-EMBOLISM STOCKING | DWL | COVIDIEN | 7802 | 1228C7DX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |