MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-09-08 for TYPE-S HEAD EXTENSION 20-CFHN-SUB2-V manufactured by Med-tec Inc. (dba Civco Medical Solutions).
[20931622]
Civco was notified that a type-s head extension joints unstuck when the patient's body was on the couch at the head extension when the patient fell and was injured on the elbow. Patient discomfort but no serious outcome was attributed to adverse event.
Patient Sequence No: 1, Text Type: D, B5
[21063887]
The device was designed with epoxy holding together the supports for the device. The strength of the epoxy can decrease when subjected to impact loads caused by collisions or improper handling. The device had impact markers possible from previous improper handling. Over time the strength can decrease enough for failure to occur. Additional information about use of product during failure or details about injuries were not known by distributor. Patient information was not provided by the distributor. Instructions for use describes and diagrams correct repositioning process of patient/clinician. Instructions for use indicates to inspect for damage/wear prior to use and not to use a damaged device. Adverse event occurred in another country. Additional contact information was not available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932738-2007-00002 |
| MDR Report Key | 910968 |
| Report Source | 08 |
| Date Received | 2007-09-08 |
| Date of Report | 2007-08-09 |
| Date Mfgr Received | 2007-08-22 |
| Device Manufacturer Date | 2003-02-25 |
| Date Added to Maude | 2007-10-18 |
| 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 | 1401 8TH STREET SOUTHEAST |
| Manufacturer City | ORANGE CITY IA 51021 |
| Manufacturer Country | US |
| Manufacturer Postal | 51021 |
| Manufacturer Phone | 7127378688 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYPE-S HEAD EXTENSION |
| Generic Name | CARBON FIBER COUCH INSERT |
| Product Code | JAI |
| Date Received | 2007-09-08 |
| Returned To Mfg | 2007-08-22 |
| Model Number | 20-CFHN-SUB2-V |
| Catalog Number | 20-CFHN-SUB2-V |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 897527 |
| Manufacturer | MED-TEC INC. (DBA CIVCO MEDICAL SOLUTIONS) |
| Manufacturer Address | 1401 8TH STREET SOUTHEAST ORANGE CITY IA 51041 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-08 |