MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-19 for ALL-FLEX KIT #80 * manufactured by Ortho Pharmaceutical.
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Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010298 |
| MDR Report Key | 50242 |
| Date Received | 1996-11-19 |
| Date of Report | 1996-11-08 |
| Date of Event | 1996-11-08 |
| Date Added to Maude | 1996-11-21 |
| 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 | ALL-FLEX KIT |
| Generic Name | DIAPHRAGM |
| Product Code | HDW |
| Date Received | 1996-11-19 |
| Model Number | #80 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 50952 |
| Manufacturer | ORTHO PHARMACEUTICAL |
| Manufacturer Address | RT 202 PO BOX 300 RARITAN NJ 088690602 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-11-19 |