MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-26 for COIL SPRING DIAPHRAGM manufactured by Ortho Pharmaceutical Corp..
[20161222]
The consumer stated that she developed toxic shock syndrome after using the diaphragm for the second time, leaving it in her body for 11 hrs. About 16 hrs after removing the diaphragm, her body was aching and 18 hrs after removal she had a fever of 103 and blood shot eyes. She then developed vomiting and diarrhea. Her physicians first thought she had a viral infection, but later diagnosed her with the staph infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000058 |
| MDR Report Key | 11063 |
| Date Received | 1994-01-26 |
| Date of Report | 1993-08-05 |
| Date Added to Maude | 1994-01-27 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | COIL SPRING DIAPHRAGM |
| Product Code | HDW |
| Date Received | 1994-01-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11063 |
| Manufacturer | ORTHO PHARMACEUTICAL CORP. |
| Manufacturer Address | RAITAN NJ 08869 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-01-26 |