FDA Adverse Event
Injury
Summary report: N
R2 MULTI-FUNCTION DEFIB PAD
MDR report key: 1013350
·
Received March 13, 2008
Report
- Report Number
- 1320208-2008-00037
- Event Type
- Injury
- Date Received
- March 13, 2008
- Date of Event
- January 22, 2008
- Report Date
- March 12, 2008
- Manufacturer
- AVENT S.A. DE R.L. DE C.V.
- Product Code
- LDD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE IS UNAVAILABLE FOR EVAL; HOWEVER, REP PHOTOS OF BURNS TO PT'S CHEST HAVE BEEN RECEIVED. WE HAVE CONTACTED THE USER FACILITY FOR MORE DETAILS OF PROCEDURE AND THE PLACEMENT OF THE ELECTRODES. A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT "PT EXPERIENCED MINOR BURNS TO CHEST AREA POST PROCEDURE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | R2 MULTI-FUNCTION DEFIB PAD | MULTIFUNCTION DEFIB PAD | LDD | AVENT S.A. DE R.L. DE C.V. | NA | 415393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |