FDA Adverse Event
Other
Summary report: N
DERMA PRENE ISOTOUCH
MDR report key: 1654387
·
Received April 7, 2010
Report
- Report Number
- 1019632-2010-00007
- Event Type
- Other
- Date Received
- April 7, 2010
- Report Date
- April 6, 2010
- Manufacturer
- ANSELL MEDICAL SDN
- Product Code
- KGO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PRODUCT WAS NOT SOLD IN THE USA, HOWEVER, SIMILAR PRODUCT IS SOLD IN THE USA. THE COMPLAINANT IS LOCATED IN (B)(6). USER EXPERIENCED SEVERE ITCHING, SKIN REDNESS, DRY SKIN AND HAS BLACK DOTS. USER IS A EYE SURGEON, HAS SLEEPLESSNESS AND IS VERY SCARED AND UNABLE TO PERFORM SURGERY. SUSPECTS CAUSE OF ALLERGY IS CHEMICALS. MEDICAL ATTENTION HAS BEEN SOUGHT AND IS CONTINUING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DERMA PRENE ISOTOUCH | SURGICAL GLOVE | KGO | ANSELL MEDICAL SDN | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |