D
Patient 1
HOSPITAL REPORTED HIGHER THAN EXPECTED DVT RATES DURING USE.
MAUDE MDR 1855785
- MDR report key
- 1855785
- Report number
- 3006242715-2010-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-09-04
- Date received
- 2010-10-01
- 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#
- Contact
- LAURIE LEWANDOWSKI
- Address
- 7550 MERIDIAN CIRCLE N STE 150 MAPLE GROVE MN 55369 US
- Phone
- 866-866-8669
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ZEUS CT PICC, 5F DL | PICC | R4 VASCULAR | LJS | 72055547 | R401D068P | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-10-01 | 0 | 1. R |
Event Narratives#
N
Patient 1
INITIAL INSPECTION OF DEVICES RETURNED EXHIBITED BLOOD CLOTS ALTHOUGH NO SPECIFIC DEVICE RELATED CAUSE WAS IDENTIFIED. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.