MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2005-03-11 for PRECISE TABLE * manufactured by Elekta Limited.
[346030]
During setup, the patient placed their fingers on the side of the bed for support. The finger was trapped when the table top was moved longitudinally. The patient sustained a severely squashed finger tip requiring microsurgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617016-2005-00009 |
| MDR Report Key | 580618 |
| Report Source | 05,06,07 |
| Date Received | 2005-03-11 |
| Date of Report | 2005-03-11 |
| Date of Event | 2005-01-07 |
| Date Mfgr Received | 2005-02-11 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2005-03-15 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARK OSBORNE, MANAGER |
| Manufacturer Street | LINAC HOUSE, FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Manufacturer Phone | 4412936542 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISE TABLE |
| Generic Name | * |
| Product Code | INQ |
| Date Received | 2005-03-11 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 570465 |
| Manufacturer | ELEKTA LIMITED |
| Manufacturer Address | LINAC HOUSE, FLEMING WAY CRAWLEY, WEST SUSSEX UK RH10 9RR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-03-11 |