FDA Adverse Event
Other
Summary report: N
LIFESTYLES ULTRA SENSITIVE RIBBED LUBRICATED
MDR report key: 395748
·
Received May 23, 2002
Report
- Report Number
- 1019632-2002-00005
- Event Type
- Other
- Date Received
- May 23, 2002
- Report Date
- May 22, 2002
- Manufacturer
- ANSELL HEALTHCARE
- Product Code
- HIS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
DURING THE PAST TWO WEEKS CUSTOMER FIRST USED LIFESTYLES ULTRA SENSITIVE RIBBED CONDOMS AND THEN THE LIFESTYLES ULTRA SENSITIVE THIN CONDOMS. HAD A TERRIBLE ALLERGIC REACTION. CUSTOMER HAD TO GO TO EMERGENCY ROOM AND THEN TO CUSTOMER'S DOCTOR FOR TREATMENT. CUSTOMER STATES THAT A RASH COVERED CUSTOMER'S GROIN, INNER THIGHS AND BUTTOCKS, AS WELL AS FRIEND'S.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTYLES ULTRA SENSITIVE RIBBED LUBRICATED | CONTRACEPTIVE DEVICE | HIS | ANSELL HEALTHCARE | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |