MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-29 for L. ULTRA THIN CONDOMS manufactured by L.
[39654367]
Bought a box of l condoms ultra thin. Three out of ten broke out of a box of 12. Threw the other two away. I haven't had a condom break on me in 15 years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060654 |
| MDR Report Key | 5476460 |
| Date Received | 2016-02-29 |
| Date of Report | 2016-02-29 |
| Date Added to Maude | 2016-03-03 |
| 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 |
| 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 | L. ULTRA THIN CONDOMS |
| Generic Name | L. ULTRA THIN CONDOMS |
| Product Code | HIS |
| Date Received | 2016-02-29 |
| Lot Number | 1403/14 |
| Device Expiration Date | 2019-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | L |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-29 |