DOLORCLAST UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-09-16 for DOLORCLAST UNK manufactured by E.m.s. Electro Medical Systems S.a..

Event Text Entries

[22126607] Inappropriate use of dolorclast on pt wrist with irreversible damage.
Patient Sequence No: 1, Text Type: D, B5

[22254130] Dolorclast is an extra corporeal shock wave device intended for use in treating soft tissue orthopedic diseases. Dolorclast is intended for treatment of chronic proximalplantar fasciitis.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3004096429-2009-00001
• MDR Report Key: 1482200
• Report Source: 00
• Date Received: 2009-09-16
• Date of Report: 2009-09-15
• Date Facility Aware: 2009-08-17
• Report Date: 2009-09-15
• Date Mfgr Received: 2009-08-17
• Date Added to Maude: 2009-09-28
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 31 CH. DE LA VUARPILLIERE
• Manufacturer City: NYON 1260
• Manufacturer Country: SZ
• Manufacturer Postal: 1260
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DOLORCLAST
• Generic Name: SHOCKWAVE GENERATOR FOR PAIN RELIEF
• Product Code: NBN
• Date Received: 2009-09-16
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: NA
• 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: NYON SZ

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2009-09-16