MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-10-11 for EXACT COUCH manufactured by *.
[255813]
A radiation therapist (rt) in training, lost the tip of their small finger when manually operating a varian model exact couch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916710-2002-00003 |
| MDR Report Key | 422423 |
| Report Source | 05,06 |
| Date Received | 2002-10-11 |
| Date of Report | 2002-10-11 |
| Date of Event | 2002-04-11 |
| Date Mfgr Received | 2002-04-12 |
| Date Added to Maude | 2002-10-21 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 3100 HANSEN WAY |
| Manufacturer City | PALO ALTO CA 943041038 |
| Manufacturer Country | US |
| Manufacturer Postal | 943041038 |
| Manufacturer Phone | 6504246662 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXACT COUCH |
| Generic Name | PATIENT SUPPORT ASSEMBLY |
| Product Code | JAI |
| Date Received | 2002-10-11 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 411474 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-10-11 |