FDA Adverse Event
Malfunction
Summary report: N
EXTENDED COATED BLADE
MDR report key: 1424540
·
Received April 1, 2009
Report
- Report Number
- 1717344-2009-00117
- Event Type
- Malfunction
- Date Received
- April 1, 2009
- Date of Event
- March 5, 2009
- Report Date
- March 6, 2009
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF INITIAL REPORT: 04/01/2009. THE SITE INFORMED US THE COATED BLADE INCIDENT SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR INVESTIGATION. THE SITE REPORTED THE EXPIRATION DATE OF THE COATED BLADE BUT NOT THE LOT #. THE EXPIRATION DATE CORRESPONDS TO 3 DIFFERENT LOT #S 111988, 112958 AND 113157.
Description of Event or Problem · 1
THE DESCRIPTION FROM THE MEDWATCH FORM (WHICH HAD NO UF/IMPORTER #) STATED: "PT HAD T&A. BEFORE DISCHARGE, THERE WAS A WHITE AREA ON RIGHT SIDE OF TONGUE + EDEMA OF TONGUE. THE PT WAS DISCHARGED CAME TO ER NEXT A.M. WITH SEVERE SWELLING AND DROOLING. ADMITTED AND TREATED AND SUBSIDED BY THAT EVENING. WE ARE TRYING TO COVER ALL BASES BY NOTIFYING THE CAUTERY COMPANY. WE DO NOT KNOW WHAT CAUSED THE WHITE AREA AND EDEMA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTENDED COATED BLADE | ELECTROSURGICAL ACCESSORY | GEI | COVIDIEN LP (VALLEYLAB) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | FORCE220PC - ES GENERATOR |