MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-04-21 for SWISS DOLORCLAST CLASSIC FT-126W manufactured by E.m.s. Electro Medical Systems S.a..
[1522930]
A doctor is complaining of tinnitus and a reduction of his hearing capacity after having treated his own neck with a dolorclast. The (b) (4) dolorclast is a non-surgical alternative for the treatment of chronic proximal plantar fasciitis for pts (b) (6) with symptoms for 6 months or more and a history of unsuccessful conservative therapy. Chronic proximal plantar fasciitis is defined as heel pain in the area of the insertion of the plantar fascia on the medial calcaneal tuberosity (see user manual fb-336/us). According to the info reported: the dolorclast had been used for an off labelled application. The doctor seems to suffer from bechterev's disease (ankylosing spondylitis), which is an inflammatory disease of the joints. Currently, there is no evidence of a link between the reported symptoms and the device. We continue the investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004096429-2010-00002 |
| MDR Report Key | 1669989 |
| Report Source | 08 |
| Date Received | 2010-04-21 |
| Date of Report | 2010-04-21 |
| Date Mfgr Received | 2010-03-23 |
| Date Added to Maude | 2010-05-03 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | CH. DE LA VUARPILLIERE 31 |
| Manufacturer City | NYON CH-1260 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-1260 |
| Manufacturer Phone | 1229944700 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWISS DOLORCLAST CLASSIC |
| Generic Name | SHOCK WAVE GENERATOR |
| Product Code | NBN |
| Date Received | 2010-04-21 |
| Model Number | FT-126W |
| Catalog Number | FT-126W |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 | CH. DE LA VUARPILLIERE 31 NYON CH-1260 SZ CH-1260 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-21 |