MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for SKYN 114043 manufactured by Suretex Prophylactics (i), Ltd..
[126216664]
User indicates that she went to her doctor complaining of irritation and burning when using the product. The doctor prescribed an estrogen cream as her doctor thought perhaps if nothing else changed, she was experiencing vaginal dryness leading to irritation during intercourse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013388459-2018-00010 |
| MDR Report Key | 8039284 |
| Date Received | 2018-11-05 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-10-22 |
| Date Facility Aware | 2018-10-24 |
| Report Date | 2018-11-05 |
| Date Reported to FDA | 2018-11-05 |
| Date Reported to Mfgr | 2018-11-05 |
| Date Added to Maude | 2018-11-05 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYN |
| Generic Name | POLYISOPRENE LAYEX CONDOM |
| Product Code | MOL |
| Date Received | 2018-11-05 |
| Catalog Number | 114043 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURETEX PROPHYLACTICS (I), LTD. |
| Manufacturer Address | 74-91 KIADB INDUSTRIAL ESTATE JIGANI II PHASE,ANEKAL TALUK BANGALORE KARNATAKA, IN-KA 560 105 IN 560 105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-05 |