MAUDE Adverse Event Report: VERIDIAN HEALTHCARE CAPSAICIN PATCH; BANDAGE, ELASTIC

Device Problem Difficult to Remove (1528)

Patient Problems Pain (1994); Skin Discoloration (2074); Burning Sensation (2146); Caustic/Chemical Burns (2549)

Event Date 02/17/2018

Event Type  No Answer Provided  

Event Description

Compensation for personal injury to leg (chemical burn), pain, suffering and loss of vacation.In (b)(6) 2018, i purchased and applied 2 capsaicin patches to my left leg in the hopes of alleviating pain.Within a few hours, the patches had began searing my leg; but i was not able to budge them.A few days later (after i was able to remove patches), i ended up in the emergency room because of the severe aching, burning sensation on my (left) leg.The next day after my hosp visit, i contacted the mfr to inform them of what had happened to me.Right away, the rep that i was speaking with [(b)(6)] asked what my nationality was, because these chemical burns were happening exclusively amongst african americans; since our initial conversation, mrs (b)(6) and i have communicated a few times; even discussing the compensation i was seeking.After approx six months from our first talk, mrs (b)(6) began telling me that someone from her executive staff would be reaching out to me to discuss a resolution, however that never happened.Subsequently, mrs (b)(6) ceased communication for a while; failing to return my calls and emails.After multiple failed attempts to reach her, i decided to contact her from a different number one day when i was out of town.To my surprise, i got through to mrs (b)(6) almost immediately.When i asked her why i had not heard back from her supv in the 2 months she had been promising, she told me they both had been on vacation.On two separate occasions, mrs (b)(6) asked me the amount of money i was seeking and i told her (b)(6) - a large portion would account for my birthday trip having to be cancelled due to my horrific burn and pain i was in.After reaching out to mrs (b)(6) to f/u on a resolution a few weeks later, she told me, yet again, that someone from the executive team would reach out to me later that day.That never happened.Approx one week later, mrs (b)(6) sent me an email indicating that her executive team would be willing to compensate me (b)(6).Note: to this day, my left leg is still discolored in the area in which chemical burn occurred.Earlier this month, i responded to the offensive email mrs (b)(6) sent via (b)(6) certified return receipt demand letter, asking that veridian healthcare compensates me in the amount we discussed by (b)(6) 2019.The letter was forwarded to 2 executive staff members and mrs (b)(6).As of this day (b)(6) 2019, i have yet to get a response.I am urgently seeking assistance with this matter and welcome any help your organization may provide.

• Brand Name: CAPSAICIN PATCH
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): VERIDIAN HEALTHCARE; 1175 lakeside drive; gurnee IL 60031
• MDR Report Key: 8739934
• MDR Text Key: 149927357
• Report Number: MW5087660
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• 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: 06/23/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1