MAUDE Adverse Event Report: COLLAGEN P. I. N. ; IMPLANT, DERMAL

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2016

Event Type  malfunction  

Event Description

The tech was using the collagen pen on my face.One of the needles fully came out and landed on the floor during the procedure.She changed it to another cartridge and the same thing happened again.She called the company in front of me during my appointment.The company did nothing other than just said i have never seen this before.She then opened a third cartridge started the procedure within 90 seconds more needles flew out of the cartridge.At this point we both were all alone and were very concerned about harming my skin and pigmentation damage with this micro needle device.I am very unhappy and i feel like this particular device is very unsafe and it needs to go back to manufacturing and fda regulations.Collagen pin.

• Brand Name: COLLAGEN P. I. N.
• Type of Device: IMPLANT, DERMAL
• MDR Report Key: 6232637
• MDR Text Key: 64368302
• Report Number: MW5067116
• Device Sequence Number: 1
• Product Code: LMH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: COLLAGEN PIN; MULTI VITAMIN
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 64