MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1998-06-10 for ALL-FLEX ARCING SPRING DIAPHRAGM UNK manufactured by R.w. Johnson Pharm. Research Institute/div Of Ortho Pharmaceutical Corp..
[17038188]
Medical chronology received from j&j legal department. This 26-year-old woman had used an all-flex arching spring diaphragm for a period of 8-12 hours on 05-mar-96. This was the second use of the diaphragm. She was seen in the emergency room on 06-mar-96 with vomiting, diarrhea, and flu-like symptoms. Treatment included iv fluids (total of 2500 ccs), ketorolac tromethamine, promethazine, hydrochloride, magnesium sulfate, acetaminophen, ceftriaxone sodium, cefoxitin, dopamine, and lorazepam. She was admitted to the intensive care unit (icu) with a diagnosis of toxic shock syndrome, and remained in icu for four days. Pt was discharged, date unspecified. Follow-up examination on 26-mar-98 was normal.
Patient Sequence No: 1, Text Type: D, B5
[17213600]
Diaphragm not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2211100-1998-00024 |
| MDR Report Key | 171932 |
| Report Source | 04 |
| Date Received | 1998-06-10 |
| Date of Report | 1998-06-01 |
| Date of Event | 1998-03-06 |
| Date Mfgr Received | 1998-05-21 |
| Date Added to Maude | 1998-06-12 |
| 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 | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL-FLEX ARCING SPRING DIAPHRAGM |
| Generic Name | DIAPHRAGM |
| Product Code | HDW |
| Date Received | 1998-06-10 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 167196 |
| Manufacturer | R.W. JOHNSON PHARM. RESEARCH INSTITUTE/DIV OF ORTHO PHARMACEUTICAL CORP. |
| Manufacturer Address | ROUTE 202 P.O. BOX 300 RARITAN NJ 088690602 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1998-06-10 |