D
Patient 1
DURING A PROCEDURE TO MIX BONE GRAFTING MATERIAL AND PLATLET RICH PLASMA, THE DUAL LIQUID APPLICATOR MANIFOLD HAD A CRACK AND PLATLET RICH PLASMA WAS SPILLED ON THE STERILE FIELD. NO PERSONNEL CONTAMINATION RESULTED.
MAUDE MDR 760168
- MDR report key
- 760168
- Report number
- 1225520-2006-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2006-06-22
- Date received
- 2006-07-12
- 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
- 40 GRISSOM RD SUITE 100 PLYMOUTH MA 02360 US
- Phone
- 508-508-5087
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SMARTJET LIQUID APPLICATOR KIT | APPLICATOR LIQUID: MANUAL SURGICAL INST | HARVEST TECHNOLOGIES, CORP. | LYC | 08623 | * | 8623-0022 | Y | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2006-07-12 | 0 |