MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-11-18 for CRONEX ORTHO S * manufactured by Sterling Diagnostic Imaging.
[15742815]
Er physician misdiagnosed a desensitized kink artifact on a radiographic image as pneumonia. The pt was also observed to be symptomatic. The pt was given an antibiotic and had a mild reaction to the antibiotic which was described as itching.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043882-1999-00001 |
| MDR Report Key | 251277 |
| Report Source | 07 |
| Date Received | 1999-11-18 |
| Date of Report | 1999-11-16 |
| Date of Event | 1999-10-21 |
| Device Manufacturer Date | 1999-05-01 |
| Date Added to Maude | 1999-11-29 |
| 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 |
| Manufacturer Contact | GLENN LONNQUIST |
| Manufacturer Street | 10 S ACADEMY ST PO BOX 19048 |
| Manufacturer City | GREENVILLE SC 29602 |
| Manufacturer Country | US |
| Manufacturer Postal | 29602 |
| Manufacturer Phone | 8644211835 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRONEX ORTHO S |
| Generic Name | RADIOGRAPHIC FILM |
| Product Code | IXW |
| Date Received | 1999-11-18 |
| Returned To Mfg | 1999-11-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 5379053010501,5379033022201 |
| ID Number | * |
| Device Expiration Date | 2001-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 243432 |
| Manufacturer | STERLING DIAGNOSTIC IMAGING |
| Manufacturer Address | P.O. BOX 267 STATON RD BREVARD NC 28712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-11-18 |