MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for LIFESTYLE ULTRA LUBRICATED CONDOMS manufactured by Ansell Healthcare Products Llc.
[122306335]
Lifestyle condoms provided in clinic were reported to break multiple times during correct use in intercourse. Staff in clinic tried putting condoms over their hands. Two staff members reported the condoms breaking on their hands. Reason for use: safe sex.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080208 |
| MDR Report Key | 7922285 |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-27 |
| Date Added to Maude | 2018-10-01 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | LIFESTYLE ULTRA LUBRICATED CONDOMS |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2018-09-28 |
| Lot Number | 1708081916 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANSELL HEALTHCARE PRODUCTS LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-28 |