N
Patient 1
MAUDE MDR 5731900
- MDR report key
- 5731900
- Report number
- 5731900
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-05-08
- Date received
- 2016-06-17
- Adverse event
- 3
- Product problem
- 0
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CO-FLEX | BANDAGE, ELASTIC | ANDOVER HEALTHCARE INC. | FQM | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-06-17 | 0 |
Event Narratives#
D
Patient 1
YOUNG FEMALE, STATUS POST (S/P) LIVER TRANSPLANT HAD A BANDAGE PLACED ON FINGER AND IT WAS NOT REMOVED UNTIL 48 HOURS LATER; THE FINGER APPEARS NECROTIC WITH POSSIBILITY OF LOSING TIP OF FINGER. PATIENT HAD FINGER STICK FOR BLOOD WORK, ACE BANDAGE APPLIED SECONDARY TO INABILITY TO STOP BLEEDING, ADMITTED, AND BANDAGE REMOVED 48 HOURS LATER ON THE UNIT. NECROTIC AREA NOTED UPON ACE BANDAGE REMOVAL.