FDA Adverse Event
Summary report: N
MEDICLIP
MDR report key: 2250810
·
Received August 30, 2011
Report
- Report Number
- 2250810
- Date Received
- August 30, 2011
- Date of Event
- September 1, 2010
- Report Date
- August 18, 2011
- Manufacturer
- MEDLINE, INC.
- Product Code
- LWK
- Report Source
- User Facility report
- Reporter Location
- KY, US
Narratives
Description of Event or Problem · 1
WHEN PREPARING A PATIENT FOR CARDIAC CATHETERIZATION AND CERTAIN OTHER PROCEDURES, BODY HAIR NEEDS TO BE REMOVED FROM THE PROCEDURE AREA. PATIENTS COMPLAINED THAT THE SHAVER USED WAS PAINFUL, PULLED THE HAIR, NICKED THE SKIN, AND CAUSED ABRASIONS TO THE AFFECTED AREA.======================MANUFACTURER RESPONSE FOR HAIR CLIPPER, MEDICLIP (PER SITE REPORTER)======================UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDICLIP | HAIR CLIPPER | LWK | MEDLINE, INC. | DYND70850 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |