MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-29 for SKYN manufactured by Suretex Ltd.
[78697898]
(b)(6) 2017 - customer contact indicating that the product had an odor and she developed a bacterial infection after use of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2017-00008 |
| MDR Report Key | 6676841 |
| Date Received | 2017-06-29 |
| Date of Report | 2017-07-31 |
| Date of Event | 2017-06-28 |
| Date Facility Aware | 2017-06-28 |
| Report Date | 2017-07-31 |
| Date Reported to FDA | 2017-07-31 |
| Date Reported to Mfgr | 2017-06-29 |
| Date Added to Maude | 2017-06-29 |
| 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 LUBRICATED MALE CONDOM |
| Product Code | MOL |
| Date Received | 2017-06-29 |
| Lot Number | 1607723416 |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURETEX LTD |
| Manufacturer Address | 31/1 MOO 4, TAMBON KHAO HUA KW AMPHUR PHUNPHIN SURATTHANI, 84130 TH 84130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-29 |