MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-25 for LIFESTYLES 600814/5500 3503 (ANSELL) manufactured by Ansell Healthcare Products Inc.
[16267493]
Customer and pts complain of burning and skin irritation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022476 |
| MDR Report Key | 343923 |
| Date Received | 2001-07-25 |
| Date of Report | 2001-07-20 |
| Date Added to Maude | 2001-07-30 |
| 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 |
| 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 | LIFESTYLES |
| Generic Name | CONDOM W/SPERMICIDE |
| Product Code | LTZ |
| Date Received | 2001-07-25 |
| Model Number | 600814/5500 |
| Catalog Number | 3503 (ANSELL) |
| Lot Number | 0812948322 |
| ID Number | 6515-01-266-3802 |
| Device Expiration Date | 2002-08-01 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 333259 |
| Manufacturer | ANSELL HEALTHCARE PRODUCTS INC |
| Manufacturer Address | INDUSTRIAL RD, PO BOX 1252 DOTHAN AL 36303 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-07-25 |