FDA Adverse Event
Other
Summary report: N
GENETIC SYSTEMS HIV-1 WESTERN BLOT
MDR report key: 391276
·
Received April 26, 2002
Report
- Report Number
- 3022521-2002-00001
- Event Type
- Other
- Date Received
- April 26, 2002
- Date of Event
- April 11, 2002
- Report Date
- April 22, 2002
- Manufacturer
- BIO-RAD LABORATORIES
- Product Code
- MVW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A LABORATORY TECHNOLOGIST AT A CUSTOMER SITE WAS SPLASHED IN THE EYE WITH THE LOW POSITIVE CONTROL FROM THE GENETIC SYSTEMS HIV-1 WESTERN BLOT KIT. THE TECHNOLOGIST SOUGHT MEDICAL CARE AS A PRECAUTION. THE CUSTOMER REQUESTED INFORMATION REGARDING HEAT INACTIVATION. THIS INFORMATION WAS FAXED THE NEXT DAY AND SENT BY FEDEX. THE CUSTOMER VERIFIED RECEIPT AND INDICATED THAT NO FURTHER INFORMATION WAS NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENETIC SYSTEMS HIV-1 WESTERN BLOT | WESTERN BLOT, IVD | MVW | BIO-RAD LABORATORIES | NA | 915453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |