MAUDE Adverse Event Report: ECLIPSE MEDCORP, LLC ECLIPSE PLATELET RICH PLASMA (PRP); PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING

Lot Number 300619EB

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Reaction (1733); Hair Loss (1877); Pain (1994)

Event Date 09/10/2019

Event Type  Injury  

Event Description

Autoimmune reaction, i was given prp by a doctor who was treating me for a medical condition.He lied to me and said it was fda approved for the intended use on my scalp.Instead it overstimulated my immune system and made all my hair fall out over the span of a couple of months after the injections.I was in so much pain.I am now forced to take immune suppressant drugs to try to reverse the damage.I was told by the doctor and nurse that prp treatment is safe and natural with zero risks.I was also given cortisone injections at the same time by the same doctor, all over my scalp, along with the prp.I found out later that this is contraindicated.And that prp is not even a standard of care for my medical condition.I was told this is the only available treatment and the doctor and nurse used scare tactics to coerce me into paying (b)(6) usd for a fake, unproven medical treatment.This seems criminal and i hope fda will crack down and prosecute these criminals before they ruin more lives.The doctor did not even perform any lab tests before treating me even though i asked for blood tests.He promotes the eclipse machine online and to patients in his private practice even after fda sent multiple warnings.There is no consequence, so they just get more brazen in their strategy to circumvent the law by manipulating patients for easy money.I hope fda and trustworthy, legitimate doctors will speak out against this to prevent it from happening to anyone else! eclipse prp is promoting this for treatment under the name marketing company called (b)(6).(b)(6), md is running online webinars to circumvent the law and promote unproven dangerous uses of prp.These companies pay doctors to train and promote its unapproved use to other doctors.They falsify supporting medical papers that make it appear legitimate.It is a scam.Why was the person using the product? hair.Did the problem stop after the person reduced the dose or stopped taking or using the product? no.Did the problem return if the person started taking or using the product again? didn't restart.Currently taking tofacitinib to reverse autoimmune alopecia.(it is the only thing that has helped to stop the painful autoimmune reaction and inflammation after i was blasted by prp).Fda safety report id # (b)(4).

• Brand Name: ECLIPSE PLATELET RICH PLASMA (PRP)
• Type of Device: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
• Manufacturer (Section D): ECLIPSE MEDCORP, LLC
• MDR Report Key: 10902862
• MDR Text Key: 218545508
• Report Number: MW5098056
• Device Sequence Number: 1
• Product Code: ORG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 300619EB
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR