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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELLIPSE A/S ELLIPSE NORDLYS INTENSE PULSED LIGHT (IPL) & LASER.

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ELLIPSE A/S ELLIPSE NORDLYS INTENSE PULSED LIGHT (IPL) & LASER. Back to Search Results
Model Number 9SYS7751
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Hematoma (1884); Ulcer (2274)
Event Date 11/20/2020
Event Type  Injury  
Manufacturer Narrative
A supplemental mdr will be submitted upon receipt of additional relevant information. Component code was left blank due to the fact that it was not determined if the device resulted in the adverse event and the component code (b)(4) was not available in esubmitter.
 
Event Description
On (b)(6) 2020, a customer reported to candela's medical director that the customer had treated a wart on the outside of the fifth digit on the right foot of a (b)(6) year-old female patient using the ellipse nordlys nd:yag applicator. The date of the treatment was (b)(6) 2020. The patient developed a hematoma which was "detained and then it popped up later by itself. " the customer reported that she covered the patient with antibiotics and the culture came back sensitive to tetracyclines. Per follow-up information, customer reported that the "patient had a thick big wart on the 5th (right) toe and developed a very deep wound that required debridement, podiatrist consultation, x-ray, and antibiotics. " customer also noted that hematoma had to be drained. Customer reported that the patient had no recent sun exposure. It was reported that the patient had a wound culture and was treated with doxycycline and prednisone. Customer reported patient injury is expected to heal. Customer reported that a test spot was performed. Reported treatment parameters: nordlys nd:yag, pulse time; 20 ms, number of pulses: 1, energy: 150 j/cm2.
 
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Brand NameELLIPSE NORDLYS
Type of DeviceINTENSE PULSED LIGHT (IPL) & LASER.
Manufacturer (Section D)
ELLIPSE A/S
agern alle 11
hoersholm, DK-29 70
DA DK-2970
Manufacturer (Section G)
ELLIPSE A/S
agern alle 11
hoersholm, DK-29 70
DA DK-2970
Manufacturer Contact
yverre bobay
251 locke drive
marlborough, MA 01752
6176696181
MDR Report Key11180496
MDR Text Key230713233
Report Number3016496662-2021-00001
Device Sequence Number1
Product Code ONF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9SYS7751
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/15/2021 Patient Sequence Number: 1
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