D
Patient 1
WHEN SURGEON WAS OPENING CASTING MATERIAL TO USE IN PT - HE DISCOVERED A PIN-LINE OBJECT MEASURING ABOUT 1" LONG (SILVER COLORED) WITH BLUNT ENDS. PATIENT WAS NOT INJURED. COMPANY WAS NOTIFIED.
MAUDE MDR 981890
- MDR report key
- 981890
- Report number
- MW5005004
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-12-18
- Date received
- 2008-01-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EZ WRAP | EZ WRAP CASTING MATERIAL | PROFESSIONAL PRODUCTS | ITG | OOEZ4-L | NONE | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-01-15 | 0 |