MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-13 for MOTIVATOR FTR 2000 * manufactured by Hogan & Hartson.
[18833186]
On 3-25-96 pt was on motivator first time and "told to use on 50% of my strength, i did so, but was so sore for days... Even hurt to breathe. " rptr advised therapist of this and told her "at my age (61) i didn't think i should be using this machine as i didn't "pump iron"-treadmill was my only planned exercise-my "biggy". Due to my complaint of severe pain & soreness my visits on march 27, 29, and april 1, 3, & 5 with prospects to begin motivator on next visit". Motivator was then used on april 1, 3, 5, 8, 10. Review physical therapy records 3-25 through 4-19. Was too sore & in too much pain to keep add'l appointments. Never returned to this physical therapy unit. Visited chiropractor on april 24, 25, 26, 30, may 2, 7, & 10 for wet heat applications, ultra sound, massage, etc. Visited orthopedic surgeon (one who did rotator cuff surgical repair of right shoulder on 1-23-96). See also his notes of 3-26, and 4-30 which reflect use of motivator and injection in left shoulder. Visits cancelled on apr 23 & april 30.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013910 |
| MDR Report Key | 170983 |
| Date Received | 1998-05-13 |
| Date of Event | 1996-03-01 |
| Date Added to Maude | 1998-06-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOTIVATOR FTR 2000 |
| Generic Name | THERAPEUTIC REHABILITATION EXERCISE MACHINE |
| Product Code | IKK |
| Date Received | 1998-05-13 |
| Model Number | MOTIVATOR FTR 2000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | K942229-FDA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 166306 |
| Manufacturer | HOGAN & HARTSON |
| Manufacturer Address | C/O MOTIVATOR, INC. 555 THIRTEENTH ST NW WASHINGTON DC 200041109 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 1998-05-13 |