FDA Adverse Event
Other
Summary report: N
CONMED NEONATAL ECG ELECTRODE W/LEADWIRE
MDR report key: 1082583
·
Received July 22, 2008
Report
- Report Number
- 1320208-2008-00098
- Event Type
- Other
- Date Received
- July 22, 2008
- Report Date
- July 22, 2008
- Manufacturer
- CONMED CORPORATION
- Product Code
- DRX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONMED RECEIVED A VAGUE REPORT OF A SKIN IRRITATION OR POSSIBLE CHEMICAL BURN OCCURRING. THIS DEVICE IS A MONITORING ECG ELECTRODE THAT NO POWER IS APPLIED TO. WE HAVE TRIED REPEATEDLY TO OBTAIN MORE SPECIFIC INFORMATION. IF WE OBTAIN ANY DATA THAT WILL ALLOW FOR AN INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT "A SKIN IRRITATION/POSSIBLE CHEMICAL BURN OCCURRED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED NEONATAL ECG ELECTRODE W/LEADWIRE | NEONATAL ECG ELECTRODE W/LEADWIRE | DRX | CONMED CORPORATION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |