FDA Adverse Event
Other
Summary report: N
GLOVE ESTEEM SMT PF SYNTHETIC SURG 6.5
MDR report key: 1622454
·
Received February 18, 2010
Report
- Report Number
- 1423507-2010-00012
- Event Type
- Other
- Date Received
- February 18, 2010
- Date of Event
- January 14, 2010
- Report Date
- February 16, 2010
- Manufacturer
- CARDINAL HEALTH
- Product Code
- KGO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT AND SAMPLE WERE FORWARDED TO THE MANUFACTURING FACILITY FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
A PHYSICIAN DEVELOPED RASH/ITCHING. HE SAW A DERMATOLOGIST AND USED A TOPICAL STEROID. THE PHYSICIAN WAS DIAGNOSED WITH CONTACT DERMATITIS. THE TOPICAL STEROID DID IMPROVE HIS SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GLOVE ESTEEM SMT PF SYNTHETIC SURG 6.5 | SURGEONS GLOVE | KGO | CARDINAL HEALTH | TS09070042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |