MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-21 for LAMINARIA * manufactured by Medgyn Products, Inc..
[182049]
Following insertion of laminaria (5 days), pt developed recurrent non-localizing fevers and sepsis. Blood culture positive for staph aureus. Found to be arising from vegetations on mitral valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019332 |
| MDR Report Key | 286527 |
| Date Received | 2000-06-21 |
| Date of Event | 2000-04-26 |
| Date Added to Maude | 2000-07-24 |
| 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 | LAMINARIA |
| Generic Name | INTRAUTERINE CERVICAL DILATOR 8MM |
| Product Code | HDY |
| Date Received | 2000-06-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 102691 |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 277264 |
| Manufacturer | MEDGYN PRODUCTS, INC. |
| Manufacturer Address | 328 N EISENHOWER LN LOMBARD IL 60148 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2000-06-21 |