FDA Adverse Event
Other
Summary report: N
LIFESTYLES SKYN LARGE
MDR report key: 3163057
·
Received May 9, 2013
Report
- Report Number
- 1019632-2013-00013
- Event Type
- Other
- Date Received
- May 9, 2013
- Report Date
- May 9, 2013
- Manufacturer
- SURETEX LTD.
- Product Code
- HIS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - ANSELL HEALTHCARE PRODUCTS LLC, IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4).
Description of Event or Problem · 1
END USER ADVISED ANSELL HEALTHCARE LLC THAT AFTER USING LIFESTYLES SKYN LARGE CONDOM SHE AND HER PARTNER STARTED TO HAVE PAIN AND BURNING AND NEEDED MEDICAL ATTENTION. THE DOCTOR PRESCRIBED BOTH AN ANTIBIOTIC AND A CREAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205185 | LIFESTYLES SKYN LARGE | LUBRICATED POLYISOPRENE CONDOM | HIS | SURETEX LTD. | 130218041C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |