MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-05-04 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) UNK manufactured by Johnson & Johnson Medical Brazil (jjmb).
[17410979]
This spontaneous report received from a pt concerns a female pt of unknown age from united states: (b)(4). The pt's height, weight and medical history were unknown. The pt was prescribed ortho all-flex arcing spring diaphragm (silicone). The start date and indication for the diaphragm was not provided. Concomitant medications were not reported. On an unknown date, the pt experienced a stroke. The pt reported in the course of her conversation "i've had a stroke". It was not clarified if the pt was currently using or had previously used the diaphragm. The pt received another call while speaking and disconnected the call before additional information could be obtained. The pt outcome was unknown for the stroke. This report was serious (serious injury).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2211100-2012-00391 |
| MDR Report Key | 2568472 |
| Report Source | 04 |
| Date Received | 2012-05-04 |
| Date of Report | 2012-05-04 |
| Date Mfgr Received | 2012-04-17 |
| Date Added to Maude | 2012-05-11 |
| 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 | 1125 TRENTON-HARBOURTON ROAD PO BOX 200 |
| 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 | 2012-05-04 |
| 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 | SAO JOSE DOS CAMPOS BR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-04 |