MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-15 for LIFESTYLES ZERO LUBRICATED LATEX CONDOM manufactured by Ansell Healthcare Products, Llc.
[123691261]
Condoms broke while in use by the patient. Pt reports that two condoms broke. The same lot number pulled in the clinic and broke easily. The packaging is hard to read, lot# is 1706082716. Additional lots that broke afterward are: 1708081916 and 1610141122.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7964726 |
| MDR Report Key | 7964726 |
| Date Received | 2018-10-15 |
| Date of Report | 2018-10-01 |
| Date of Event | 2018-09-27 |
| Report Date | 2018-10-01 |
| Date Reported to FDA | 2018-10-01 |
| Date Reported to Mfgr | 2018-10-15 |
| Date Added to Maude | 2018-10-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 ZERO LUBRICATED LATEX CONDOM |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2018-10-15 |
| Model Number | LUBRICATED LATEX |
| Lot Number | 1706082716 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANSELL HEALTHCARE PRODUCTS, LLC |
| Manufacturer Address | 1635 INDUSTRIAL RD. DOTHAN AL 36303 US 36303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-15 |