MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-04-20 for TYPE-S HEAD EXTENSION 20-CFHN-SUB2-V manufactured by Civco Medical Solutions, Med-tec Inc..
[16639789]
Civco was notified that a type-s head extension joint broke near the locking mechanism and allowed the patient to fall. The patient was lying flat on their back as they adjusted themslef of the type-s head extension. The type-s head extension broke and the patient fell about 2-3 feet. The patient was evaluated by x-ray and no injury was identified.
Patient Sequence No: 1, Text Type: D, B5
[16653706]
Clinician/hospital glued joint together prior to returning for evaluation which made evaluation of the original joint adhesive impossible. Patient repositioned self putting excessive pressure on worn device. Instructions for use describes and diagrams correct repositioning process of patient/clinician. Instructions for use indicate to inspect for damage/wear prior to use and not to use a damaged device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932738-2007-00001 |
| MDR Report Key | 950580 |
| Report Source | 06 |
| Date Received | 2007-04-20 |
| Date of Report | 2007-04-11 |
| Date of Event | 2007-03-26 |
| Date Mfgr Received | 2007-03-26 |
| Device Manufacturer Date | 2003-06-01 |
| Date Added to Maude | 2007-11-21 |
| 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 | 1401 8TH ST SE |
| Manufacturer City | ORANGE CITY IA 51041 |
| Manufacturer Country | US |
| Manufacturer Postal | 51041 |
| Manufacturer Phone | 7127278688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| 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 | IWY |
| Date Received | 2007-04-20 |
| Model Number | 20-CFHN-SUB2-V |
| Catalog Number | 20-CFHN-SUB2-V |
| Lot Number | 2901 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 921898 |
| Manufacturer | CIVCO MEDICAL SOLUTIONS, MED-TEC INC. |
| Manufacturer Address | 1401 8TH ST. SE ORANGE CITY IA 51041 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-20 |