MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-11 for SKYN 814522 manufactured by Suretex Prophylactics (i), Ltd..
[102068867]
On (b)(6) 2018 complainant stated girlfriend is allergic to latex and they purchased a latex alternative product. After use of the product, girlfriend had pain and localized swelling. Girlfriend sought medical attention from primary care provided and gyneacologist. They prescribed her antibiotics and told her to get benadryl and alieve. I don't have my receipt from the initial purchase.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013388459-2018-00004 |
| MDR Report Key | 7329767 |
| Date Received | 2018-03-11 |
| Date of Report | 2018-03-10 |
| Date of Event | 2018-03-06 |
| Date Facility Aware | 2018-03-06 |
| Report Date | 2018-03-10 |
| Date Reported to FDA | 2018-03-10 |
| Date Reported to Mfgr | 2018-03-12 |
| Date Added to Maude | 2018-03-11 |
| 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 MALE CONDOM |
| Product Code | MOL |
| Date Received | 2018-03-11 |
| Catalog Number | 814522 |
| Lot Number | 1612970222 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 24 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 | 2018-03-11 |