MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-06-14 for LIFESTYLES SKYN 7303 manufactured by Suretex-thailand.
[3693706]
Customer informed ansell healthcare products llc that after using the lifestyles polyisoprene lubricated condom she had repeatedly developed yeast infections.
Patient Sequence No: 1, Text Type: D, B5
[11075544]
(b)(4). Ansell healthcare products llc is submitting this report on behalf of suretex-(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1019632-2013-00014 |
| MDR Report Key | 3208856 |
| Report Source | 04 |
| Date Received | 2013-06-14 |
| Date of Report | 2013-06-14 |
| Date Facility Aware | 2013-06-12 |
| Report Date | 2013-06-14 |
| Date Reported to FDA | 2013-06-14 |
| Date Reported to Mfgr | 2013-06-14 |
| Date Mfgr Received | 2013-06-14 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2013-07-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TAMMY MCGRIFF |
| Manufacturer Street | 1635 INDUSTRIAL RD. |
| Manufacturer City | DOTHAN AL 36303 |
| Manufacturer Country | US |
| Manufacturer Postal | 36303 |
| Manufacturer Phone | 3346152566 |
| Manufacturer Street | 331 MOO 4 TAMBOL KHAO HUA KHWIA |
| Manufacturer City | AMPHUR PHUNPHIN, SURAT THANI 84130 |
| Manufacturer Postal Code | 84130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESTYLES SKYN |
| Generic Name | LUBRICATED POLYISOPRENE CONDOM |
| Product Code | MOL |
| Date Received | 2013-06-14 |
| Catalog Number | 7303 |
| Lot Number | 1205240600 |
| Device Expiration Date | 2015-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURETEX-THAILAND |
| Manufacturer Address | SURAT THANI TH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-14 |