MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2003-11-21 for LUMBAR EXTENSION MACHINE MEDX LUMBAR LU53 manufactured by Medx.
[349761]
Pt treated for work related back injury beginning in 1996. X-ray diagnosed as acute lumbar strain. Pt prescribed and took place 10/96 - 12/96. Re-examination in 1/97 showed herniated disk in low back. Started series of pt sessions using med and lumbar 2/97 - 4/97. In 4/97, pt, while undergoing isometric test under supervision by pt felt a "pop" and immediate pain in low back. Therapist removed pt from lumbar machine and applied ice, pt transported to er. Investigation indicates osteoporosis had been diagnosed but not reported. This info may not have been available to pt. Follow-up x-ray and mri show compression fracture. Follow-up x-ray shows fracture healed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051095-2003-00001 |
| MDR Report Key | 497035 |
| Report Source | 00,07 |
| Date Received | 2003-11-21 |
| Date of Report | 2003-11-19 |
| Date of Event | 1997-03-24 |
| Date Mfgr Received | 2003-11-06 |
| Device Manufacturer Date | 1993-08-01 |
| Date Added to Maude | 2003-11-25 |
| 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 | SUSAN BOWEN, DIR OF QUALITY |
| 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 MACHINE |
| Product Code | ISD |
| Date Received | 2003-11-21 |
| 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 | 485773 |
| Manufacturer | MEDX |
| Manufacturer Address | 1401 NE 77TH ST. OCALA FL 34479 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 | 2003-11-21 |