MAUDE Adverse Event Report: PFIZER / PF CONSUMER HEALTHCARE 1 LLC THERMACARE HEATWRAP - ADVANCED NECK PAIN THERAPY; PACK, HOT OR COLD, DISPOSABLE

Lot Number (L) EC2269

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/21/2020

Event Type  malfunction  

Event Description

The patch was used and caused a severe allergic reaction (swelling) in the whole body for several days.The product didn't label or specify the active ingredients.Allergic to aspirin.Therapy duration: 1 hour.Diagnose for use: neck pain therapy.

• Brand Name: THERMACARE HEATWRAP - ADVANCED NECK PAIN THERAPY
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): PFIZER / PF CONSUMER HEALTHCARE 1 LLC
• MDR Report Key: 10619279
• MDR Text Key: 209846809
• Report Number: MW5097013
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): Y
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2023
• Device Lot Number: (L) EC2269
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 65