MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2005-12-23 for LUMBAR EXTENSION MACHINE MEDX LUMBAR LU53 manufactured by Medx.
[15448555]
Patient alleges he was injured on lumbar extension machine claiming the machine improperly exerted force on his body causing serious orthopedic and neurological injury. According to his doctor, the pt began lumbar rehabilitation using the lu53 machine in 2003 and responded favorably. He had several sessions for 21 days with substantial improvement noted on follow up testing in 2003. On same day, after the testing and during the dynamic portion of his rehabilitation session, the pt was moving too fast and ignored direction to slow down. After the fifth repetition the patient experienced an acute sharp/shooting pain in his left lumbo-sacral/sij region with immediate attendant left lower extremity pain extending to just below the level of the knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051095-2005-00001 |
| MDR Report Key | 656330 |
| Report Source | 00,07 |
| Date Received | 2005-12-23 |
| Date of Report | 2005-12-21 |
| Date of Event | 2003-12-01 |
| Date Mfgr Received | 2004-05-06 |
| Device Manufacturer Date | 1991-05-01 |
| Date Added to Maude | 2005-12-28 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE MINGOIA, DIRECTOR |
| Manufacturer Street | 1401 NE 77TH ST |
| Manufacturer City | OCALA FL 34479 |
| Manufacturer Country | US |
| Manufacturer Postal | 34479 |
| Manufacturer Phone | 3526222112 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMBAR EXTENSION MACHINE |
| Generic Name | MEASURING EXERCISE DEVICE |
| Product Code | ISD |
| Date Received | 2005-12-23 |
| Model Number | MEDX LUMBAR |
| Catalog Number | LU53 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 645814 |
| Manufacturer | MEDX |
| Manufacturer Address | * OCALA FL * US |
| Baseline Brand Name | LUMBAR EXTENSION MACHINE |
| Baseline Generic Name | MEASURING EXERCISE DEVICE |
| Baseline Model No | MEDX LUMBAR |
| Baseline Catalog No | * |
| Baseline ID | LOAD CELL# 3752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-12-23 |