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

Device Problems Device Reprocessing Problem (1091); Contamination (1120); Fluid/Blood Leak (1250); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

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.

• Brand Name: MICROPEN
• Type of Device: MICROPEN MICRO NEEDLING DEVICE
• Manufacturer (Section D): ECLIPSE AESTHETICS
• MDR Report Key: 2978650
• MDR Text Key: 3131598
• Report Number: MW5029110
• Device Sequence Number: 1
• Product Code: GFE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• 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 Received: 02/20/2013
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2013
• 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