FDA Adverse Event
Other
Summary report: N
LIFESTYLES X2
MDR report key: 1802455
·
Received August 9, 2010
Report
- Report Number
- 1019632-2010-00014
- Event Type
- Other
- Date Received
- August 9, 2010
- Report Date
- August 9, 2010
- Manufacturer
- SURETEX LTD.
- Product Code
- HIS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXEMPTION NUMBER (B)(6) - ANSELL HEALTHCARE PRODUCTS LLC IS SUBMITTING THIS REPORT ON BEHALF OF SURETAX LTD. ADDITIONAL INFO RECEIVED FROM CUSTOMER: SHE STATED THAT SHE IS NOT ALLERGIC TO LATEX.
Description of Event or Problem · 1
CUSTOMER SENT A COMPLAINT STATING THAT SHE HAD AN ALLERGIC REACTION TO LIFESTYLES X2 CONDOMS. ALTHOUGH NO MEDICAL ATTENTION WAS NEEDED, SHE HAD APPLIED A CORTICOSTEROID CREAM OVER THE AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTYLES X2 | LUBRICATED LATEX CONDOM | HIS | SURETEX LTD. | 0812051816 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |