FDA Adverse Event
Other
Summary report: N
GLV SURG ESTEEM MICRO SYN PF SZ 6
MDR report key: 1735951
·
Received June 16, 2010
Report
- Report Number
- 1423507-2010-00029
- Event Type
- Other
- Date Received
- June 16, 2010
- Date of Event
- March 14, 2010
- Report Date
- June 16, 2010
- Manufacturer
- CARDINAL HEALTH
- Product Code
- KGO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT AND SAMPLE WERE FORWARDED TO THE MANUFACTURING FACILITY FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
A THEATER ROOM NURSE DEVELOPED ITCHING/ IRRITATION. SHE SOUGHT MEDICAL TREATMENT AND WAS GIVEN PRESCRIPTIVE MEDICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GLV SURG ESTEEM MICRO SYN PF SZ 6 | SURGEON'S GLOVES | KGO | CARDINAL HEALTH | TS09080397 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |