FDA Adverse Event
Other
Summary report: N
ANSELL LIFESTYLES ULTRASENSITIVE
MDR report key: 485679
·
Received September 4, 2003
Report
- Report Number
- 2320840-2003-03012
- Event Type
- Other
- Date Received
- September 4, 2003
- Report Date
- August 28, 2003
- Manufacturer
- LMR INTERNATIONAL, INC.
- Product Code
- HIS
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ANSELL HEALTHCARE SENT A COMPLAINT REGARDING LOT #01127I56AV CONCERNING A REPORTED "ALLERGIC REACTION". SAMPLES WERE SENT FOR EVALUATION (NRL CONDOMS/SILICONE LUBRICANT). IN FOLLOW UP WITH ANSELL, LMR WAS INFORMED THAT THE PATIENT HAD BEEN TESTED AND WAS NOT ALLERGIC TO NRL. A SILICONE MSDS WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANSELL LIFESTYLES ULTRASENSITIVE | CONDOM | HIS | LMR INTERNATIONAL, INC. | 8453 | 01127I56AV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |