FDA Adverse Event
Injury
Summary report: N
IMMULITE REAGENT WEDGE
MDR report key: 429140
·
Received November 21, 2002
Report
- Report Number
- 2017183-2002-00001
- Event Type
- Injury
- Date Received
- November 21, 2002
- Date of Event
- April 20, 2001
- Report Date
- November 12, 2002
- Manufacturer
- DIAGNOSTIC PRODUCTS CORP
- Product Code
- JJQ
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
LAB TECH ATTEMPTED TO CLOSE AN IMMULITE WEDGE COMPONENT ON A COUNTER TOP AND IT SLIPPED OUT FROM UNDER THE HAND CAUSING THE THUMB TO SWELL DUE TO A TORN LIGAMENT. NO PHYSICIAN REPORT OF THIS INJURY WAS AVAILABLE FROM THE INITIAL REPORTER. CUSTOMER DID NOT PROVIDE INFO REGARDING PRODUCT IDENTIFICATION. DIAGNOSTIC PRODUCTS CORP DID NOT BECOME AWARE OF THIS INCIDENT UNTIL IT WAS REPORTED TO A TECHNICAL SERVICE REP VISITING THE SITE ON 11/5/2002.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMULITE REAGENT WEDGE | IN VITRO DIAGNOSTIC TEST KIT | JJQ | DIAGNOSTIC PRODUCTS CORP | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |