D
Patient 1
UNWANTED CORROSION APPEARED ON THE DEVICE, WHICH MAY CAUSE (CAUSED) STRUCTURAL DAMAGE TO THE UNIT. FURTHER INVESTIGATION IS REQUIRED.
MAUDE MDR 2720773
- MDR report key
- 2720773
- Report number
- MW5026699
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-08-06
- Date received
- 2012-08-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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 | HALO | OVERHEAD TUBE HOLDER | CORE LABS, LLC | IYB | 02-000 | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-08-27 | 0 | 1. O |