MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-07-22 for MED-TEC, TYPE-S SYSTEM MT-CFHN-SUB2 manufactured by Med-tec,inc..
[293702]
A pt was set up on the type-s on the varian exact couch. The exact-bar is permanently attached to the type-s and it was attached to the table. The therapist pushed on the exact-bar to make sure it was secure. The pt laid down on the type-s, but pt was too high, so they asked pt to move down so they could get the mask on. When pt did that, pt and the type-s fell head first off the head end of the couch. According to the therapist, the pt did not have any visible injuries. Pt got up off the floor by themselves, but they sent pt to have a ct.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932738-2003-00001 |
| MDR Report Key | 485134 |
| Report Source | 05 |
| Date Received | 2003-07-22 |
| Date of Report | 2003-07-22 |
| Date of Event | 2003-07-15 |
| Date Mfgr Received | 2003-07-15 |
| Date Added to Maude | 2003-09-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1401 8TH STREET, SE PO 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 | MED-TEC, TYPE-S SYSTEM |
| Generic Name | CARBON FIBER HEAD, NECK, AND SHOULDER BASE |
| Product Code | IWY |
| Date Received | 2003-07-22 |
| Model Number | MT-CFHN-SUB2 |
| Catalog Number | MT-CFHN-SUB2 |
| Lot Number | NA |
| 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 | 474021 |
| Manufacturer | MED-TEC,INC. |
| Manufacturer Address | 1401 8TH ST. S.E. P.O. BOX 320 ORANGE CITY IA 51041 US |
| Baseline Brand Name | MED-TEC TYPE S SYSTEM |
| Baseline Generic Name | RADIOGRAPHIC HEAD HOLDER |
| Baseline Model No | MT-CFHN-SUB2 |
| Baseline Catalog No | MT-CFHN-SUB2 |
| Baseline ID | BASE, CARBON FI |
| Baseline Device Family | PATIENT POSITIONING & IMMOBILIZATION |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K933227 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-22 |