FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN TEDS
MDR report key: 1423025
·
Received March 30, 2009
Report
- Report Number
- 1017072-2009-00002
- Event Type
- Malfunction
- Date Received
- March 30, 2009
- Date of Event
- March 23, 2009
- Report Date
- March 23, 2009
- Manufacturer
- COVIDIEN LP
- Product Code
- DWL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 03/27/2009. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN IN 2009, THAT A CUSTOMER HAS AN ISSUE WITH A TED STOCKING. THE CUSTOMER STATES THAT PT DEVELOPED A DEEP TISSUE INJURY ON ONE FOOT. CUSTOMER STATES PT HAD A SMALL BRUISE ON EACH METATARSAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN TEDS | TED STOCKING | DWL | COVIDIEN LP | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |