FDA Adverse Event
Other
Summary report: N
LIFESTYLE CONDOM
MDR report key: 220986
·
Received April 26, 1999
Report
- Report Number
- MW4002490
- Event Type
- Other
- Date Received
- April 26, 1999
- Report Date
- April 7, 1999
- Manufacturer
- ANSELL, INC.
- Product Code
- LTZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ADD'L INFO REC'D FROM MFR ON 06/17/1999: ONE LIFESTYLES SPERMICIDALLY LUBRICATED CONDOM, LOT NUMBER 810908824, WAS SUBJECTED TO STANDARD WATER BURST TESTING AS WELL AS VISUAL INSPECTION. NO BREAKAGE, HOLES, WEAKNESSES OR DEFECTS WERE FOUND. REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT REVEALED NO HOLES, BREAKAGE OR DEFECTS NOTED DURING THE PRODUCTION OF THIS LOT. COMPLAINT HISTORY SEARCH CONFIRMED THAT NO OTHER COMPLAINTS HAD BEEN FILED AGAINST THIS LOT OF CONDOMS FOR ANY REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTYLE CONDOM | SPERMICIDALLY LUBRICATED WITH NONOXYNOL-9 CONDOMS | LTZ | ANSELL, INC. | NA | 0810908824 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |