FDA Adverse Event
Summary report: N
PRO SERIES
MDR report key: 2170268
·
Received July 15, 2011
Report
- Report Number
- 2170268
- Date Received
- July 15, 2011
- Date of Event
- July 15, 2011
- Report Date
- July 15, 2011
- Manufacturer
- MEDLINE
- Product Code
- FYF
- Report Source
- User Facility report
- Reporter Location
- ME, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SURGICAL TECHNICIAN NOTED THAT THE SURGICAL CAPS, "BOUFFONT CAPS" WERE A MUCH DARKER COLOR THAN USUAL WHEN THE WAS BOX OPENED. THE TECHNICIAN NOTED THAT THE LEFT SIDE OF HER HAIRLINE WAS RED "LIKE A BURN." SHE WAS SENT TO EMPLOYEE HEALTH FOR FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRO SERIES | CAP, SURGICAL | FYF | MEDLINE | * | 1005121063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |