MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-06-17 for MEDTEC, TYPE-S SYSTEM MT-CFHN-006 manufactured by Medtec.
[391325]
The pt was set up on the type-s board. The pt arched their back while laying on board and the board tilted and slid off the table. The pt and the type-s board slid headfirst off of the treatment table. According to the therapist, the pt did not have any visible injuries and refused any medical treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932738-2005-00009 |
| MDR Report Key | 615134 |
| Report Source | 05 |
| Date Received | 2005-06-17 |
| Date of Report | 2005-06-17 |
| Date of Event | 2005-06-10 |
| Date Mfgr Received | 2005-06-10 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2005-06-21 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | P.O. BOX 320 1401 8TH ST S.E. |
| 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 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTEC, TYPE-S SYSTEM |
| Generic Name | CARBON FIBER HEAD, NECK, AND SHOULDER BASE |
| Product Code | IWY |
| Date Received | 2005-06-17 |
| Model Number | MT-CFHN-006 |
| Catalog Number | MT-CFHN-006 |
| 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 | 604903 |
| Manufacturer | MEDTEC |
| Manufacturer Address | * ORANGE CITY IA * US |
| Baseline Brand Name | MEDTEC TYPE-S SYSTEM |
| Baseline Generic Name | RADIOGRAPHIC HEAD HODLER |
| Baseline Model No | MT-CFHN-006 |
| Baseline Catalog No | MT-CFHN-006 |
| Baseline ID | BASE, CARBON FI |
| Baseline Device Family | PATIENT POSITIONING AND IMMOBILIZATION |
| 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 | 2005-06-17 |