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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EL. EN. ELECTRONIC ENGINEERING SPA DEKA SMARTXIDE2 LASER

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EL. EN. ELECTRONIC ENGINEERING SPA DEKA SMARTXIDE2 LASER Back to Search Results
Catalog Number 105-7030-100
Device Problems Human Factors Issue; Adverse Event Without Identified Device or Use Problem
Event Date 03/31/2016
Event Type  Injury  
Event Description

Patient had medical intervention following a laser treatment due to severe bladder/urethral pain.

 
Manufacturer Narrative

This initial medwatch report is in response to fda report mw5062264 and following el en spa's medwatch report: 3001431138-2016-00007. (b)(4) (importer) was unable to investigate this incident when initially made aware on october 4, 2016, then notified el en (device manufacturer) to which they were also unsuccessful in obtaining investigation details. El en, as the device manufacturer, decided to submit medwatch report: 3001431138-2016-00007 in response to the mw5062264 report on september 30, 2016 and subsequent follow-up report 3001431138-2016-00007 fu#1 on november 4, 2016. (b)(4) was once again made aware of fda report mw5062264 on june 5, 2017 and notified el en accordingly. (b)(4) contacted the patient and was successful in receiving a response, now able to obtain information regarding the adverse event / treatment site. When at the laser treatment site, patient complained of severe pain in the bladder/urethral area from the laser procedure. But during post treatment, patient had declined any follow-up laser procedures, examinations, or medications when offered by the customer's onsite doctor. Patient then had medical intervention from a urologist upon a doctor referral due to severe pain experienced in the laser treated area. The treatment technique and actions performed for the laser procedure were not followed per the device's clinical reference guide, which was provided to the customer site with the laser device. This is because the patient in this incident was already being treated with an antibiotic medication for a yeast infection prior to the laser procedure. The patient having an "active localized or systemic infection or an open wound in area being treated" in the proposed treatment (vaginal) area prior to the procedure is contraindicated by the device's clinical reference guide. The operator of the laser had still performed the laser procedure on the patient despite the clinical reference guide saying otherwise. The device was not evaluated since user error had contributed to this incident. This updated information supplements medwatch report: 3001431138-2016-00007 and responds to the fda report mw5062264.

 
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Brand NameDEKA SMARTXIDE2 LASER
Type of DeviceDEKA SMARTXIDE2 LASER
Manufacturer (Section D)
EL. EN. ELECTRONIC ENGINEERING SPA
via baldanzese 17
calenzano 50041
ITALY 50041
MDR Report Key6679280
Report Number1222993-2017-00028
Device Sequence Number1
Product CodeGEX
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Physician
Device Catalogue Number105-7030-100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/29/2017
Distributor Facility Aware Date06/05/2017
Event Location No Information
Date Report TO Manufacturer06/21/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/29/2017 Patient Sequence Number: 1
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