FDA Adverse Event
Other
Summary report: N
MEDICHOICE MC1310P
MDR report key: 3163082
·
Received May 29, 2013
Report
- Report Number
- 9681860-2013-00011
- Event Type
- Other
- Date Received
- May 29, 2013
- Date of Event
- May 6, 2013
- Report Date
- May 13, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MLN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATION ELECTRODES. THE CUSTOMER REPORTS THAT DURING A SCHEDULED CARDIOVERSION, THE NURSE NOTED A REDDENED AND BLISTERED AREA WHERE THE DEFIB PAD HAD BEEN. THE CUSTOMER FURTHER REPORTS THE DOCTOR PRESCRIBED SILVADENE CREAM FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234141 | MEDICHOICE MC1310P | DEFIBRILLATION ELECTRODES | MLN | COVIDIEN | 3583MC1310P | 306709 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |