FDA Adverse Event
Summary report: N
GLASS LENS STERILE MICROSCOPE DRAPE
MDR report key: 1410227
·
Received July 1, 2009
Report
- Report Number
- 1410227
- Date Received
- July 1, 2009
- Date of Event
- June 22, 2009
- Report Date
- July 1, 2009
- Manufacturer
- BUYMD, INC.
- Product Code
- KKX
- Report Source
- User Facility report
- Reporter Location
- MN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING SURGICAL PROCEDURE, A HAIR WAS FOUND ON THE VELCRO EYE STRAP OF THE DRAPE COVERING THE MICROSCOPE. THE DRAPE WAS MARKED STERILE ON THE PACKAGING. THE SURGERY STAFF WAS APPROPRIATELY GOWNED/HAIR COVERED. THE DRAPE WAS NOT USED DIRECTLY ON THE PATIENT. THE INCIDENT WAS REPORTED TO THE DRAPE MANUFACTURER. IN FOLLOW UP, THEY REPORTED THEY HAVE ALL MECHANISMS IN PLACE TO PREVENT THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GLASS LENS STERILE MICROSCOPE DRAPE | DRAPE, SURGICAL STERILE | KKX | BUYMD, INC. | G650DL | 80729C8078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |