FDA Adverse Event
Malfunction
Summary report: N
SENSICARE VINYL GOLVES
MDR report key: 275583
·
Received April 28, 2000
Report
- Report Number
- 9613193-2000-00003
- Event Type
- Malfunction
- Date Received
- April 28, 2000
- Manufacturer
- MAXXIM BELGIUM N.V.
- Product Code
- LYZ
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER CLAIMS BLOOD SEEPED THROUGH GLOVES DURING A TRAUMA SITUATION IN EMERGENCY ROOM. NO IMMEDIATE HEALTH CONCERN. THERE IS THE POTENTIAL THAT THE HEALTH CARE PROVIDER MAY HAVE BEEN IN CONTACT WITH A BLOOD BORNE PATHOGEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENSICARE VINYL GOLVES | NON-STERILE POWDERED MEDICAL EXAMINATION GLOVES | LYZ | MAXXIM BELGIUM N.V. | NA | 00202G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |