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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ECLIPSE AESTHETICS MICROPEN MICROPEN MICRO NEEDLING DEVICE

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ECLIPSE AESTHETICS MICROPEN MICROPEN MICRO NEEDLING DEVICE Back to Search Results
Event Date 01/24/2013
Event Type  Malfunction  
Event Description

Blood-borne exposure of eclipse micropen micro needling device (class i medical device) during platelet-rich plasma micro needling procedure which represents a significant biohazard for contamination of micropen with blood-borne pathogens between patient use. The sterile single use cartridge housing the 12x33 ga needles with plastic connection became grossly contaminated with the pt¿s blood and during disconnection of the disposable needle system there was visible blood contamination in the micropen attachment chamber which oozed and dripped out of the device. There is no way to clean the device or sterilize the internal working of the micropen device. I notified eclipse aesthetics, the mfr of the micropen device by phone and requested replacement of all 3 of the micropen devices i purchased from them. In their advertising, eclipse stated prp and other drug constituent micro needling is an indication for use, however, this use poses a severe public health risk in that blood-borne pathogens can be unknowingly transmitted with subsequent use of the device during routine use where dermal bleeding or prp percutaneous administration is performed. Diagnosis: collagen induction therapy.

 
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Brand NameMICROPEN
Type of DeviceMICROPEN MICRO NEEDLING DEVICE
Manufacturer (Section D)
ECLIPSE AESTHETICS
MDR Report Key2978650
Report NumberMW5029110
Device Sequence Number1
Product CodeGFE
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 02/20/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/20/2013
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 02/20/2013 Patient Sequence Number: 1
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