MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-26 for LIFESTYLE CONDOM UNK manufactured by Ansell, Inc..
[158177]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002490 |
| MDR Report Key | 220986 |
| Date Received | 1999-04-26 |
| Date of Report | 1999-04-07 |
| Date Added to Maude | 1999-04-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESTYLE CONDOM |
| Generic Name | SPERMICIDALLY LUBRICATED WITH NONOXYNOL-9 CONDOMS |
| Product Code | LTZ |
| Date Received | 1999-04-26 |
| Returned To Mfg | 1999-04-12 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | 0810908824 |
| ID Number | NA |
| Device Expiration Date | 2001-11-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 214307 |
| Manufacturer | ANSELL, INC. |
| Manufacturer Address | 1500 INDUSTRIAL RD. DOTHAN AL 36303 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-04-26 |