MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for SKYN ELITE 164672 manufactured by Suretex Prophylactics (i), Ltd..
[110220637]
On (b)(6) 2018 customer indicated major irritation following use of the product. Private area became very red, swollen, and burning sensation. Customer indicated that they went to see a doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013388459-2018-00007 |
| MDR Report Key | 7573494 |
| Date Received | 2018-06-06 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-05-23 |
| Date Facility Aware | 2018-05-23 |
| Report Date | 2018-06-06 |
| Date Reported to FDA | 2018-06-06 |
| Date Reported to Mfgr | 2018-06-06 |
| Date Added to Maude | 2018-06-06 |
| 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 ELITE |
| Generic Name | POLYISOPRENE CONDOM |
| Product Code | MOL |
| Date Received | 2018-06-06 |
| Returned To Mfg | 2018-08-23 |
| Catalog Number | 164672 |
| Lot Number | 1801P20722 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 5 MO |
| 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 | 2018-06-06 |