D
Patient 1
NEEDLE BROKE OUTSIDE OF PATIENT DURING THE 2ND PLACEMENT RUN WHICH OCCURRED AFTER DOCTOR HIT BONE AND WHEN TRYING TO PASS SAME NEEDLE AGAIN.
MAUDE MDR 267713
- MDR report key
- 267713
- Report number
- 1018233-2000-00006
- Event key
- 0
- Event type
- 3
- Date received
- 2000-03-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- VIVIAN STEPHENS
- Address
- 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD BRACHYTHERAPY NEEDLE | SEED IMPLANT NEEDLE | C.R. BARD, INC. | IWJ | NA | 218201 | UNK | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2000-03-03 | 0 | 1. O |