MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1998-03-24 for CRONEX ORTHO L * manufactured by Sterling Diagnostic Imaging.
[7767061]
The radiology administrator has not responded to co's written request for the required product info to perform an investigation. The radiology administrator communicated verbally to co's sales management that he reviewed co's written request with the radiologist involved with the event and chairman of the radiology dept. They elected not to reply to co's request and consider the issue closed. Co has continued to monitor complaint records with no indication of a trend relative to this alleged event. Please consider this co's final report.
Patient Sequence No: 1, Text Type: N, H10
[19160696]
A radiologist commented to a sterling di account executive alleging that the sterling radiographic film used in the radiographic study of a hip had failed to image a fracture. The pt rec'd a follow-up x-ray at another location where upon the fracture was detected. No serious injury or adverse health consequence was indicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043882-1998-00001 |
| MDR Report Key | 159612 |
| Report Source | 05,07 |
| Date Received | 1998-03-24 |
| Date of Report | 1998-03-20 |
| Date of Event | 1998-02-24 |
| Date Mfgr Received | 1998-02-25 |
| Date Added to Maude | 1998-03-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRONEX ORTHO L |
| Generic Name | RADIOGRAPHIC FILM |
| Product Code | IWZ |
| Date Received | 1998-03-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 155455 |
| Manufacturer | STERLING DIAGNOSTIC IMAGING |
| Manufacturer Address | STATON RD. PO BOX 267 BREVARD NC 28712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-03-24 |