MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-05-13 for LIFESTYLERS SKYN 7412 manufactured by Suretex Ltd.
[17260785]
The customer informed ansell healthcare products, llc that after using a lifestyles polyisoprene lubricated condom she has suffered severe vaginal burning for over a month.
Patient Sequence No: 1, Text Type: D, B5
[17622419]
(b)(4). Ansell healthcare products llc is submitting this report on behalf of suretex ltd.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1019632-2014-00007 |
| MDR Report Key | 3855869 |
| Report Source | 04 |
| Date Received | 2014-05-13 |
| Date of Report | 2014-05-13 |
| Date Facility Aware | 2013-05-08 |
| Report Date | 2014-05-13 |
| Date Reported to FDA | 2014-05-13 |
| Date Reported to Mfgr | 2014-05-13 |
| Date Mfgr Received | 2014-05-08 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2014-06-10 |
| 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 Street | 1635 INDUSTRIAL RD. |
| Manufacturer City | DOTHAN AL 36303 |
| Manufacturer Country | US |
| Manufacturer Postal | 36303 |
| Manufacturer Phone | 3346152566 |
| Manufacturer G1 | SURETEX LTD |
| Manufacturer Street | 331 MOO 4 TAMBOI KHAO HUA KHWIA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESTYLERS SKYN |
| Generic Name | LUBRICATED POLYISOPRENE CONDOM |
| Product Code | MOL |
| Date Received | 2014-05-13 |
| Catalog Number | 7412 |
| Lot Number | 1210123316 |
| Device Expiration Date | 2015-09-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURETEX LTD |
| Manufacturer Address | SURAT THANI TH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-13 |