MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-03-01 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) UNK manufactured by Johnson & Johnson Medical Brazil.
[16752495]
This spontaneous report was received from a pt and concerned herself an (b)(6) female from the united states: (b)(4). The patient? S height, weight and medical history were not reported. In 2010, the patient was switched from the ortho coil spring diaphragm (see (b)(4)) to ortho all-flex arcing spring diaphragm (silicone) and used for prolapsed uterus (off label use). Concomitant medications were not reported. In 2010, the patient stated she became allergic to silicone that she clarified as painful hives that burst in her vagina, legs, arms, and chest. She also reported that since 2010 she has had? Discomfort upon urination and bacterial infections? With other unk side effects. It was not reported if the patient continues to use the ortho all-flex arcing spring diaphragm (silicone). The patient outcome was not reported for bacterial infection, discomfort with urination, silicone allergy, painful hives and off label use. The patient did not want to share any further info for this report. The product was not available for eval and the lot number was not provided. This report was serious (device malfunction). This case, involving the same patient is linked to 2012-01067 and 2012-01071.
Patient Sequence No: 1, Text Type: D, B5
[16949016]
The product was not available for eval and the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242843-2013-00155 |
| MDR Report Key | 3063321 |
| Report Source | 04 |
| Date Received | 2013-03-01 |
| Date of Report | 2013-02-21 |
| Date of Event | 2010-01-01 |
| Date Facility Aware | 2013-02-21 |
| Date Reported to Mfgr | 2013-03-01 |
| Date Mfgr Received | 2013-02-21 |
| Date Added to Maude | 2013-05-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 1125 TRENTON-HARBOURTON ROAD |
| Manufacturer City | TITUSVILLE NJ 08560 |
| Manufacturer Country | US |
| Manufacturer Postal | 08560 |
| Manufacturer Phone | 2153257722 |
| 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 | 2013-03-01 |
| 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 | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL BRAZIL |
| Manufacturer Address | SAO JOSE DOS CAMPOS BR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-01 |