MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-03-26 for SRO 33/100 X-RAY TUBE ASSEMBLY 9874-005-16017 NA manufactured by Philips Systeme Medezin.
[17419844]
Oil leaked from the x-ray tube housing and dripped into the pt's eye. The pt reported eye irritation (stinging sensation). The pt's eye was flushed with solution and no further medical treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1997-00014 |
| MDR Report Key | 80461 |
| Report Source | 06 |
| Date Received | 1997-03-26 |
| Date of Report | 1997-03-08 |
| Date of Event | 1997-03-08 |
| Date Facility Aware | 1997-03-08 |
| Report Date | 1997-03-08 |
| Date Reported to FDA | 1997-03-26 |
| Date Reported to Mfgr | 1997-03-08 |
| Date Mfgr Received | 1997-03-08 |
| Date Added to Maude | 1997-04-03 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SRO 33/100 X-RAY TUBE ASSEMBLY |
| Generic Name | X-RAY TUBE |
| Product Code | ITY |
| Date Received | 1997-03-26 |
| Model Number | 9874-005-16017 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 79929 |
| Manufacturer | PHILIPS SYSTEME MEDEZIN |
| Manufacturer Address | * HAMBURG GM |
| Baseline Brand Name | RO 33/100 X-RAY TUBE ASSEMBLY |
| Baseline Generic Name | X-RAY TUBE & HOUSING |
| Baseline Model No | 9874-005-16017 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | SRO/SRT 33/100 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-03-26 |