MICROPEN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-20 for MICROPEN manufactured by Eclipse Aesthetics.

Event Text Entries

[3131598] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5029110
• MDR Report Key: 2978650
• Date Received: 2013-02-20
• Date of Report: 2013-02-20
• Date of Event: 2013-01-24
• Date Added to Maude: 2013-02-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MICROPEN
• Generic Name: MICROPEN MICRO NEEDLING DEVICE
• Product Code: GFE
• Date Received: 2013-02-20
• Returned To Mfg: 2013-02-20
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ECLIPSE AESTHETICS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-02-20