MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for SKYN manufactured by .
[121590149]
09/25/2018 - information to identify the specific product and manufacturer not available as of this date.
Patient Sequence No: 1, Text Type: N, H10
[121590150]
(b)(6) 2018 - user indicated the condom slipped off during intercourse and could not be removed from female partner. They went to the emergency room to remove the condom. No other issue identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013388459-2018-00008 |
| MDR Report Key | 7905692 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-09-24 |
| Date Facility Aware | 2018-09-25 |
| Report Date | 2018-09-25 |
| Date Reported to FDA | 2018-09-25 |
| Date Reported to Mfgr | 2018-09-25 |
| Date Added to Maude | 2018-09-25 |
| 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 CONDOM |
| Product Code | MOL |
| Date Received | 2018-09-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | IN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-25 |