MAUDE Adverse Event Report: PFIZER CONSUMER HEALTHCARE THERMACARE SHOULDER HEAT WRAPS 3 BOXES EACH OF 11 JOINT/MUSCLE HEAT; "PACK, HOT OR COLD, DISPOSABLE"

Device Problem Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2019

Event Type  No Answer Provided  

Event Description

I would like to report a problem with the heat wrap thermacare product company.The fda posted information on a recall and i would have made many efforts since to contact the company and have yet to get a response.Thermacare is ignoring customers regarding this recall and it is completely unacceptable as many other customers may be exposed to the same issue.I have been trying to get in touch for two months now with no response besides an automatic generic email.Please advise.

• Brand Name: THERMACARE SHOULDER HEAT WRAPS 3 BOXES EACH OF 11 JOINT/MUSCLE HEAT
• Type of Device: "PACK, HOT OR COLD, DISPOSABLE"
• Manufacturer (Section D): PFIZER CONSUMER HEALTHCARE
• MDR Report Key: 8382092
• MDR Text Key: 137686838
• Report Number: MW5084552
• Device Sequence Number: 3
• Product Code: IMD
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/26/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 30 YR