N
Patient 1
MAUDE MDR 5055972
- MDR report key
- 5055972
- Report number
- 5055972
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-08-04
- Date received
- 2015-09-04
- Adverse event
- 3
- Product problem
- 3
- 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 | BOUFFANT CAPS PRO SERIES | CAP, SURGICAL | MEDLINE INDUSTRIES | FYF | NON30233B | 54214121119 | * | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-09-04 | 0 |
Event Narratives#
D
Patient 1
A NEW BOX OF BOUFFANT CAPS WAS OPENED. UPON OPENING THE INTACT BOX, A PAIR OF FINGERLESS GLOVES WERE FOUND INSIDE THE BOX.