D
Patient 1
REMINGTON MEDICAL, INC SALES REP WAS CONTACTED BY (B)(6) MGR ON (B)(4) 2011 AND REPORTED THAT THE VALVE OF THE INTRODUCER BECAME DISPLACED WHEN THE DILATOR WAS REMOVED FROM THE SHEATH (PRIOR TO TEAR-AWAY).
MAUDE MDR 2034648
- MDR report key
- 2034648
- Report number
- 1056553-2011-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-02-17
- Date received
- 2011-03-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- 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 | 100-07 | SEAL-A-WAY INTRODUCER KIT | REMINGTON MEDICAL, INC. | DYB | 100-07 | 100-07 | 102912 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-03-17 | 0 |
Event Narratives#
N
Patient 1
MFG EVAL IS IN PROCESS AND UPDATE TO FORM 3500A WILL BE SUBMITTED UPON COMPLETION OF EVAL.