MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-02 for SCOPO 76 4512 129 06371 NA manufactured by Philips Systeme Medezin.
[61665]
Allegedly, nine radiology technicians have sore wrists due to the reported difficulty in loading 35x35cm cassettes in the spot film device. Reportedly, eight of the nine technicians have sought medical attention an dare now wearing protective wrist braces when operating the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1997-00019 |
| MDR Report Key | 89077 |
| Report Source | 05,06 |
| Date Received | 1997-05-02 |
| Date of Report | 1997-04-03 |
| Date of Event | 1997-04-03 |
| Date Facility Aware | 1997-04-03 |
| Report Date | 1997-04-03 |
| Date Reported to Mfgr | 1997-04-03 |
| Date Mfgr Received | 1997-04-03 |
| Date Added to Maude | 1997-05-08 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCOPO 76 |
| Generic Name | SPOT FILM DEVICE |
| Product Code | IXL |
| Date Received | 1997-05-02 |
| Model Number | 4512 129 06371 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 88073 |
| Manufacturer | PHILIPS SYSTEME MEDEZIN |
| Manufacturer Address | * HAMBURG GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-05-02 |