MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-06-16 for TYPE-S SYSTEM MT-CFHN-C manufactured by Civco.
[18479939]
Customer notified civco that although physicians were not performing any treatment at the time, the patient shifted themselves, applying extra weight to the superior side of the table and fell to the ground. Patient was diagnosed to have a fractured back. Saftey straps had been sent to the facility in 2005, but they do not use them.
Patient Sequence No: 1, Text Type: D, B5
[18595926]
Facility does not want to discuss the issue or provide information regarding the patient with civco. Based on initial comments from the facility, the patient repositioned themselves without assistance. The user manual contains cautions and warnings for the operator not to allow the patient to reposition themselves without assistance. Also, safety straps were supplied to the facility, but they do not use them.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932738-2006-00004 |
| MDR Report Key | 727127 |
| Report Source | 05 |
| Date Received | 2006-06-16 |
| Date of Report | 2006-06-14 |
| Date of Event | 2006-06-01 |
| Date Mfgr Received | 2006-06-01 |
| Date Added to Maude | 2006-06-21 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1401 8TH STREET NE P.O. BOX 320 |
| Manufacturer City | ORANGE CITY IA 51041 |
| Manufacturer Country | US |
| Manufacturer Postal | 51041 |
| Manufacturer Phone | 7127378688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYPE-S SYSTEM |
| Generic Name | CARBON FIBER HEAD, NECK, AND SHOULDER BASE |
| Product Code | IWY |
| Date Received | 2006-06-16 |
| Model Number | MT-CFHN-C |
| Catalog Number | MT-CFHN-C |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 715560 |
| Manufacturer | CIVCO |
| Manufacturer Address | * ORANGE CITY IA * US |
| Baseline Brand Name | TYPE-S SYSTEM |
| Baseline Generic Name | CARBON FIBER HEAD, NECK, AND SHOULDER BASE |
| Baseline Model No | MT-CFHN-C |
| Baseline Catalog No | MT-CFHN-C |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-06-16 |