MAUDE Adverse Event Report: PFIZER THERMACARE; THERMACARE MUSCLE PAIN THERAPY

Device Problem Material Disintegration (1177)

Patient Problems Erythema (1840); Skin Discoloration (2074)

Event Date 03/03/2017

Event Type  Injury  

Event Description

I applied the thermacare muscle heat wrap as directed.The wrap disintegrated during use and left red marks on leg where adhesive had been.I had to literally scrape the adhesive off my skin.There is still discoloration weeks later.Is the product over-the-counter: yes.Frequency: daily.How was it taken or used: transdermal.Why was the person using the product: pulled muscle.

• Brand Name: THERMACARE
• Type of Device: THERMACARE MUSCLE PAIN THERAPY
• Manufacturer (Section D): PFIZER
• MDR Report Key: 6423918
• MDR Text Key: 70682949
• Report Number: MW5068571
• Device Sequence Number: 1
• Product Code: IMD
• 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: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 53