MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-07-17 for PROPHYLACTIC LATEX SPERMICIDE LUBRICATED NONOXYNOL-9 * manufactured by Hankook Latex Gongup Co., Ltd..
[166340]
Numerous complaints received by local public health office regarding subject brand name condom prophylactic. Item ruptures or breaks during sexual intercourse; great potential for unwarranted pregnancies and transmission of sexually transmitted diseases including hiv/aids. Consultation with other public health offices confirm similar complaints. Contacted a total of 36 offices, eight offices distributed same brand condom. Six of the eight offices voices the same complaint. Each office questioned consumers regarding method of condom use (e. G. , oral/anal sex, improper use, etc). Breakage occurred during vaginal intercourse, single condom use, with no add'l lubricant use. It is suspected that breakage could be caused by substandard material or mfg, and not consumer misuse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019300 |
| MDR Report Key | 286108 |
| Date Received | 2000-07-17 |
| Date of Report | 2000-07-07 |
| Date Added to Maude | 2000-07-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROPHYLACTIC LATEX SPERMICIDE LUBRICATED NONOXYNOL-9 |
| Generic Name | CONDOM |
| Product Code | LTZ |
| Date Received | 2000-07-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 9CX035-P |
| ID Number | NSN 6515-01-266-3802 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 276857 |
| Manufacturer | HANKOOK LATEX GONGUP CO., LTD. |
| Manufacturer Address | 622-1 HUPYEONG-DONG CHUNCHON-CITY, KANGWON-DO KS 200-160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-07-17 |