THERMACARE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for THERMACARE manufactured by Pfizer Inc..

Event Text Entries

[128726032] I purchased 6 different kinds of patches; 1 for my lower back, upper back, my arms, i applied the therma care patches to both my arms while at work after 20-30 mins the begin to burn badly, so i went to the bathroom at work and removed. The nurse over me told me to wash my arms off. The next day my arms were discolored, itching, and patches in spots all over my arms for months. Worry experience ever and to verify my story i worked at (b)(6). How was it taken or used? Topical; date the person first started taking or using the product: (b)(6) 2017; date the person stopped taking or using the product: (b)(6) 2017. Reason for use: aching muscles.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5081642
• MDR Report Key: 8110576
• Date Received: 2018-11-27
• Date of Report: 2018-11-27
• Date of Event: 2017-10-13
• Date Added to Maude: 2018-11-28
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: THERMACARE
• Generic Name: PACK, HOT OR COLD, REUSABLE
• Product Code: IME
• Date Received: 2018-11-27
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PFIZER INC.

Device Sequence Number: 2

• Brand Name: THERMACARE
• Generic Name: PACK, HOT OR COLD, REUSABLE
• Product Code: IME
• Date Received: 2018-11-27
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: PFIZER INC.

Device Sequence Number: 3

• Brand Name: THERMACARE
• Generic Name: PACK, HOT OR COLD, REUSABLE
• Product Code: IME
• Date Received: 2018-11-27
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: PFIZER INC

Device Sequence Number: 4

• Brand Name: THERMACARE
• Generic Name: PACK, HOT OR COLD, REUSABLE
• Product Code: IME
• Date Received: 2018-11-27
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: PFIZER INC.

Device Sequence Number: 5

• Brand Name: THERMACARE
• Generic Name: PACK, HOT OR COLD, REUSABLE
• Product Code: IME
• Date Received: 2018-11-27
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: PFIZER INC.

Device Sequence Number: 6

• Brand Name: THERMACARE
• Generic Name: PACK, HOT OR COLD, REUSABLE
• Product Code: IME
• Date Received: 2018-11-27
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: PFIZER, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-11-27