FDA Adverse Event
Other
Summary report: N
GIV SURG ESTEEM BLUE PF POLYISOPRENE 6.5
MDR report key: 1752873
·
Received June 30, 2010
Report
- Report Number
- 1423507-2010-00031
- Event Type
- Other
- Date Received
- June 30, 2010
- Date of Event
- April 14, 2010
- Report Date
- June 28, 2010
- Manufacturer
- CARDINAL HEALTH
- Product Code
- KGO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE NURSE REACTED TO SIZE 6.5 (CAT# 2D73EB65, LOT# TS09120073) AND SIZE 7.0 (CAT# 2D73EB70, LOT# TS09120032) OF THIS GLOVE. THE COMPLAINT AND SAMPLES WERE FORWARDED TO THE MANUFACTURING PLANT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
OPERATING ROOM NURSE HAD AN ALLERGIC REACTION TO THIS GLOVE. SHE USED PRESCRIPTIVE CREAM AND WILL BE SEEING A DERMATOLOGIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIV SURG ESTEEM BLUE PF POLYISOPRENE 6.5 | SURGEONS GLOVE | KGO | CARDINAL HEALTH | TS09120073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |