MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-09 for LIFESTYLES NOT PROVIDED manufactured by .
[40023798]
At this time, insufficient information has been provided by the initial reporter to identify which of the two manufacturing facilities the device could have come from. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[40023799]
Contact advised that he and girlfriend used a lifestyle condom (no specific product name, lot code, or product identifier information provided). Afterwards, there were complications that resulting in spending 8 hours in a emergency room at a hospital. No other information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2016-00001 |
| MDR Report Key | 5490245 |
| Date Received | 2016-03-09 |
| Date of Report | 2016-03-09 |
| Date of Event | 2016-02-17 |
| Date Facility Aware | 2016-02-17 |
| Report Date | 2016-03-09 |
| Date Reported to FDA | 2016-03-09 |
| Date Added to Maude | 2016-03-09 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | LIFESTYLES |
| Generic Name | NATURAL RUBBER LATEX CONDOM |
| Product Code | HIS |
| Date Received | 2016-03-09 |
| Model Number | NOT PROVIDED |
| Catalog Number | NOT PROVIDED |
| Lot Number | NOT PROVIDED |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-03-09 |