MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-15 for INFO REQUESTED FROM HOSP X-RAY MACHINE FLAT BED (OLDER MODEL) manufactured by Unk.
[2353511]
Exam: dx4-0446 hip left 2+ views (b)(6). (b)(6), x-ray tech/examiner and x-ray tech/ trainee, rm #rad-ah. Technique: ap pelvis & frog leg view left hip. No acute fracture dislocation. Injury/symptoms resulting from hip x-rays: skin remains tender to the touch. Sensation of internal tearing of skin. Sharp shooting pains (nerves run directly through x-rayed areas. Touching of skin results in sharp shooting pains in both (touched skin areas and untouched skin areas, resulting from the x-rays). (b)(6) hosp refused to examine me or to provide any assistance in this matter. Something went wrong during this x-ray procedure either with the x-ray tech or the person he was training and or the x-ray machine. I have requested info regarding x-ray machine from vhd to no avail. However they did inform me that the x-ray machine had been serviced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023123 |
| MDR Report Key | 2341877 |
| Date Received | 2011-11-15 |
| Date of Report | 2011-11-07 |
| Date of Event | 2011-10-27 |
| Date Added to Maude | 2011-11-21 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFO REQUESTED FROM HOSP |
| Generic Name | X-RAY MACHINE FLAT BED (OLDER MODEL) |
| Product Code | IZO |
| Date Received | 2011-11-15 |
| Model Number | X-RAY MACHINE FLAT BED (OLDER MODEL) |
| Operator | OTHER |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2011-11-15 |