MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-08 for EXOGEN ULTRASOUND HEALING SYSTEM THM MODEL 2000 NA manufactured by Exogen, Inc..
[15614897]
Dr states system works very well for pts when it works, but after 50-60 uses the head wears out or gets gel trapped inside, leading to short circuiting. In his case, he has returned the device for repair or replacement. The co checks it out and returns it to him saying that it is functioning. He finds that it isn't and loses more time between treatments. Rptr feels that the co should provide better service to their pts, by sending new units in exchange for faulty ones and perhaps implement an automatic replacement if the head after 50-60 treatments. These steps, the rptr feels, would prevent pts from losing treatment effects waiting for repair or replacement. If these steps are not taken, the rptr feels that the device should be recalled for redesign.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015854 |
| MDR Report Key | 213347 |
| Date Received | 1999-03-08 |
| Date of Report | 1999-03-08 |
| Date of Event | 1999-02-03 |
| Date Added to Maude | 1999-03-11 |
| 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 | EXOGEN ULTRASOUND HEALING SYSTEM |
| Generic Name | EXTERNAL ULTRASOUND HEALING SYSTEM |
| Product Code | LPQ |
| Date Received | 1999-03-08 |
| Model Number | THM MODEL 2000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 207001 |
| Manufacturer | EXOGEN, INC. |
| Manufacturer Address | 10 CONSTITUTION AVE. PISCATAWAY NJ 08855 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-03-08 |