D
Patient 1
"IN THE CUSTOMER KIT, THERE IS A SPINAL INTRODUCER NEEDLE AND THE NEEDLE DETACHED FROM THE HUB AND WAS BURIED IN THE PT. THE NEEDLE WAS REMOVED AFTER AN INCISION WAS MADE."
MAUDE MDR 503016
- MDR report key
- 503016
- Report number
- 2523676-2003-00058
- Event key
- 0
- Event type
- 3
- Date of event
- 2003-11-13
- Date received
- 2003-12-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ART MORSE
- Address
- 901 MARCON BLVD ALLENTOWN PA 18103 US
- Phone
- 610-610-6102
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PENCAN | CUSTOM SPINAL KIT | B. BRAUN MEDICAL, INC. | HAS | NA | 560218 | UNK | K932569 | N | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2003-12-23 | 0 | 1. R |