MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-04-27 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) UNK manufactured by Johnson & Johnson Medical Brazil (jjmb).
[1638626]
This spontaneous report received from a patient concerns an (b)(6), female, from the united states: (b)(4). The patient's medical history and concurrent conditions included: uterine prolapse. The patient's height and weight were not reported. The patient had a previous history of using the ortho all-flex arcing spring diaphragm made of latex for over twenty (20) years without any incident or adverse event. The patient was treated with an ortho all-flex arcing spring diaphragm made of silicone for uterine prolapse. Concomitant medications were not reported. On an unknown date, the patient reported that two (2) hours after inserting the diaphragm, she developed a severe infection (vaginal and urinary tract). The patient stated that she "would not be able to use any kind of vaginally insertable device again because of the damage she now has to live with". The patient's outcome was unknown for the vaginal infection and urinary tract infection. This report was serious (medically significant).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2211100-2010-00010 |
| MDR Report Key | 1750835 |
| Report Source | 04 |
| Date Received | 2010-04-27 |
| Date of Report | 2010-04-26 |
| Date Mfgr Received | 2010-04-09 |
| Date Added to Maude | 2010-07-13 |
| 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 |
| Reporter Occupation | UNKNOWN |
| 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 (SILICONE) |
| Generic Name | HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES |
| Product Code | HDW |
| Date Received | 2010-04-27 |
| 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 | JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB) |
| Manufacturer Address | BR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-27 |