FDA Adverse Event
Other
Summary report: N
GOODMAN CO. LTD
MDR report key: 823314
·
Received March 1, 2007
Report
- Report Number
- 2243801-2007-00008
- Event Type
- Other
- Date Received
- March 1, 2007
- Date of Event
- January 30, 2007
- Report Date
- February 21, 2007
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- DYB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE IN THE INCIDENT WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. WITHOUT THE SAMPLE A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.
Description of Event or Problem · 1
PACING FAILURE. UNABLE TO PACE. CONSIDERED A BROKEN CABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOODMAN CO. LTD | PACING CATHETER | DYB | B. BRAUN MEDICAL, INC. | NA | 60893765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |