N
Patient 1
(B)(4) FOLLOW UP SUBMISSION WILL BE COMPLETED POST INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
MAUDE MDR 7979791
- MDR report key
- 7979791
- Report number
- 9680904-2018-00025
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-09-01
- Date received
- 2018-10-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- BDX ANNA WEHRHEIM
- Address
- 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JAMSHIDI NEEDLE BONE MARROW 16G ADJ LEN | BIOPSY NEEDLES & TRAYS | CAREFUSION, INC | FSH | DIN1518X | 0001233035 | Y | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-10-18 | 0 | 1. O |
Event Narratives#
D
Patient 1
THE SEAL IS OPEN PARTIALLY ON THE PRODUCT POUCH.