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U.S. Department of Health and Human Services

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

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COLLAGEN P. I. N. IMPLANT, DERMAL Back to Search Results
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.
 
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Brand NameCOLLAGEN P. I. N.
Type of DeviceIMPLANT, DERMAL
MDR Report Key6232637
MDR Text Key64368302
Report NumberMW5067116
Device Sequence Number1
Product Code LMH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received01/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/04/2017 Patient Sequence Number: 1
Treatment
COLLAGEN PIN; MULTI VITAMIN
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