FDA Adverse Event
Other
Summary report: N
EDICHOICE MC1310P
MDR report key: 3163083
·
Received May 29, 2013
Report
- Report Number
- 9681860-2013-00012
- Event Type
- Other
- Date Received
- May 29, 2013
- Date of Event
- May 9, 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 PATIENT WAS DEFIBRILLATED TWO TIMES AT 100 JOULES AND 200 JOULES, RESPECTIVELY. THE CUSTOMER REPORTS THE DOCTOR ORDERED SILVADENE CREAM FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233934 | EDICHOICE MC1310P | DEFIBRILLATION ELECTRODES | MLN | COVIDIEN | 3583MC1310P | 306709 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |