FDA Adverse Event
Malfunction
Summary report: N
ESTEEM STRETCHY NITRILE MICROTEXTURED CHEMO TESTED
MDR report key: 2823087
·
Received November 1, 2012
Report
- Report Number
- MW5027497
- Event Type
- Malfunction
- Date Received
- November 1, 2012
- Report Date
- November 1, 2012
- Manufacturer
- CARDINAL HEALTH
- Product Code
- FMC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
EXAM GLOVES WERE FOUND TO HAVE PINPOINT HOLES AND TEARS WHEN HEALTHCARE PROFESSIONAL APPLIED TO HANDS. ALSO REPORTS OF THE GLOVES SPLITTING FROM CUFF TO FINGERTIPS WHEN PLACED ON HANDS. THIS ISSUE INVOLVES FIVE DIFFERENT LOT NUMBERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESTEEM STRETCHY NITRILE MICROTEXTURED CHEMO TESTED | EXAM GLOVES | FMC | CARDINAL HEALTH | 8G12C052 | ||
| 2 | ESTEEM STRETCHY NITRILE MICROTEXTURED CHEMO TESTED | EXAM GLOVES | FMC | CARDINAL HEALTH | 8G12D013 | ||
| 3 | ESTEEM STRETCHY NITRILE MICROTEXTURED CHEMO TESTED | EXAM GLOVES | FMC | CARDINAL HEALTH | 9A12H015 | ||
| 4 | ESTEEM STRETCHY NITRILE MICROTEXTURED CHEMO TESTED | EXAM GLOVES | FMC | CARDINAL HEALTH | 8G12C020 | ||
| 5 | ESTEEM STRETCHY NITRILE MICROTEXTURED CHEMO TESTED | EXAM GLOVES | FMC | CARDINAL HEALTH | 8G12D013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |