MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,05 report with the FDA on 2010-04-20 for ALL-FLEX ARCING SPRING DIAPHRAGM UNK manufactured by Ortho-mcneil Pharmaceutical Corp., Usa.
[15559650]
Report received from literature. Von mollendorf ce, van damme l, moyes ja, rees vh, callahan mm, mauck ck, et al. Results of a safety and feasibility study of the diaphragm used with acidform gel or ky jelly. Contraception 2010;81:232-239. The pt's medical history, height and weight were unk. The pt was enrolled in a randomized, placebo-controlled safety and feasibility trial of a diaphragm with vaginal gel during 6 months of use among 120 hiv-negative sexually active women. The women received an ortho all-flex arcing spring diaphragm made of natural rubber along with acidform gel for the prevention of pregnancy. No concomitant medications were reported. On an unspecified date, the pt became pregnant. The pt outcome was unk. This report is serious (medically significant).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2211100-2010-00007 |
| MDR Report Key | 1671181 |
| Report Source | 01,03,05 |
| Date Received | 2010-04-20 |
| Date of Report | 2010-04-20 |
| Date Mfgr Received | 2010-03-16 |
| Date Added to Maude | 2011-05-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 100 TOURNAMENT DRIVE |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal | 19044 |
| Manufacturer Phone | 2153257685 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL-FLEX ARCING SPRING DIAPHRAGM |
| Generic Name | HDW-CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES |
| Product Code | HDW |
| Date Received | 2010-04-20 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-MCNEIL PHARMACEUTICAL CORP., USA |
| Manufacturer Address | RARITAN NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-20 |