MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-06 for ORTHOPAEDIC EXTRACORPOREAL SHOCK WAVE THERAPY FT-174 manufactured by E.m.s. Electro Medical Systems S.a..
[3738536]
Many of the staff using the machines are saying that they have been suffering pain and aches in their wrists, thumbs and lower arms during and post application of treatments to patients.
Patient Sequence No: 1, Text Type: D, B5
[11411067]
According to the information provided, the symptoms reported could be related to an intensive use of the device. In the handpiece instructions for use fb-286/3 and fb-326/3, we recommend to not use the device more than two continuous hour to avoid any harmful effect and in our swiss dolorclast device instruction for use fb-533/3, we mention that "extended use should be avoided in order to prevent the harmful effect of vibrations on the handpiece. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004096429-2013-00003 |
| MDR Report Key | 3469058 |
| Report Source | 05 |
| Date Received | 2013-11-06 |
| Date of Report | 2013-10-02 |
| Date Mfgr Received | 2013-10-02 |
| Date Added to Maude | 2013-11-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | CHEMIN DE LA VUARPILLIERE 31 |
| Manufacturer City | NYON 1260 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 1260 |
| Manufacturer Phone | 1229944700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOPAEDIC EXTRACORPOREAL SHOCK WAVE THERAPY |
| Generic Name | SWISS DOLORCLAST CLASSIC DEVICE |
| Product Code | NBN |
| Date Received | 2013-11-06 |
| Model Number | FT-174 |
| Catalog Number | FT-174 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
| Manufacturer Address | CHEMIN DE LA VUARPILLIERE 31 NYON 1260 SZ 1260 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-06 |