FDA Adverse Event
Other
Summary report: N
PERFORMA 2"SQ, 4/PK 5519-67
MDR report key: 3999003
·
Received August 5, 2014
Report
- Report Number
- 2183164-2014-00003
- Event Type
- Other
- Date Received
- August 5, 2014
- Date of Event
- July 14, 2014
- Report Date
- July 14, 2014
- Manufacturer
- COVIDIEN
- Product Code
- GXY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH AN ELECTRODE. THE DISTRIBUTOR REPORTS THAT A PATIENT RECEIVED SKIN IRRITATION. THE CUSTOMER FURTHER STATES THAT THE IRRITATION WAS ADDRESSED WITH SANTYL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456048 | PERFORMA 2"SQ, 4/PK 5519-67 | ELECTRODES | GXY | COVIDIEN | EP84101 | 313455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |