D
Patient 1
INSUFFICIENT SOLDER APPLIED DURING THE ASSEMBLY OF THE DEVICE, THUS RESULTING THE CABLE WIRE TO DETACH FROM THE CONNECTOR.
MAUDE MDR 919636
- MDR report key
- 919636
- Report number
- 1056553-2007-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-08-13
- Date received
- 2007-09-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- CYNTHIA CROFT
- Address
- 6830 MEADOWRIDGE CT. ALPHARETTA GA 30005 US
- Phone
- 770-770-7708
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FL-601-97B FAST LOC | DISPOSABLE EXTENSION CABLE | REMINGTON MEDICAL, INC. | DSA | FL-601-97B | FL-601-97B | 0624410 | N | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-09-25 | 0 | 1. L |
Event Narratives#
N
Patient 1
THE DISPOSABLE EXTENSION CABLES MANUFACTURED BY REMINGTON MEDICAL ARE SUBJECTED TO A 100% FINAL INSPECTION FOR DIELECTRIC AND CONTINUITY CRITERIA THAT MEETS OR EXCEEDS THE REQUIREMENTS. MANUFACTURING RECORDS INDICATE THE CABLE PASSED BOTH ELECTRICAL TESTS. THERE HAS NOT BEEN OTHER REPORTS OF THIS NATURE IN RELATION TO THE MANUFACTURING LOT NUMBER IN ADDITION REMINGTON MEDICAL HAS NOT RECEIVED ANY OTHER RELATED REPORTS.