MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-23 for FUJIRADIOGRAPH DUPLICATOR T-450D manufactured by Techno-aide.
[10284]
Lid of radiograph duplicator closed with force on right wwrist of operator's hand. Distal right radius fracture. Reported carpal tunnel syndrome resulted. Surgery was performed to release carpal tunnel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2443168-1994-00001 |
| MDR Report Key | 19099 |
| Date Received | 1994-09-23 |
| Date of Report | 1994-09-08 |
| Date of Event | 1994-03-24 |
| Date Facility Aware | 1994-08-25 |
| Report Date | 1994-09-08 |
| Date Reported to FDA | 1994-09-08 |
| Date Reported to Mfgr | 1994-09-08 |
| Date Added to Maude | 1995-01-24 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUJIRADIOGRAPH DUPLICATOR |
| Generic Name | RADIOGRAPH DUPLICATOR |
| Product Code | IXK |
| Date Received | 1994-09-23 |
| Model Number | T-450D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19024 |
| Manufacturer | TECHNO-AIDE |
| Manufacturer Address | 7117 CENTENNIAL BLVD NASHVILLE TN 37209 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-09-23 |