MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-12 for LIFESTYLES UNK manufactured by .
[54500517]
On (b)(6) 2016 consumer upon using the product got a severe reaction and had to go to the emergency room because genital area had swelling. No other information provided at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2016-00008 |
| MDR Report Key | 5943598 |
| Date Received | 2016-09-12 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-09-06 |
| Date Facility Aware | 2016-09-06 |
| Report Date | 2016-09-12 |
| Date Reported to FDA | 2016-09-12 |
| Date Added to Maude | 2016-09-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | LIFESTYLES |
| Generic Name | LATEX CONDOM |
| Product Code | HIS |
| Date Received | 2016-09-12 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-09-12 |