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 |