THERMACARE NECK, SHOULDER & WRIST

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-16 for THERMACARE NECK, SHOULDER & WRIST manufactured by Pfizer Consumer Health Care.

Event Text Entries

[183648046] Event verbatim [preferred term] discomfort and pain/skin sensitive to prolonged heat/more pain and discomfort/a series of blisters/rashes and swollen patches of skin/burned by product/ three bumps on top part of back of neck [burns second degree] , kept it on from approximately 8-9 hours. [device use error] ,. Case narrative:this is spontaneous report from a contactable consumer via us fda. The regulatory authority report number was mw5092981. A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for muscle pain and to treat pain and discomfort on shoulder neck. The patient medical history was not reported. There were no concomitant medications. The patient applied thermacare neck pan therapy (up to 16 hours relief) heat wrap on left shoulder. Covering part of neck and back to treat muscle pain. Kept it on from approximately 8-9 hours. The patient felt some discomfort and pain on (b)(6) 2020 after taking the wrap off figured skin sensitive to prolonged heat. Woke up during the middle of the night with more pain and discomfort and noticed a series of blisters. Rashes and swollen patches of skin. The patient realized that he/she had been burned by the product. Skin still felt painful to the touch to the point that even his/her shirt touching the affected skin cause pain and discomfort. The patient had three bumps on the top part of the back of his/her neck. While the wrap did not touch this part of his/her neck. They were not there before and the patient believed this reaction to the heat/burned caused by the wrap on his/her skin. The patient was planning on going to the pharmacy and try to get some medicine to alleviate the pain and discomfort. The us-fda considered these events to be serious due to important medical event (serious injury). The action taken in response to the events for thermacare heatwrap was unknown. The outcome of the events was unknown. Additional information has been requested and will be provided as it becomes available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1066015-2020-00074
• MDR Report Key: 9836716
• Report Source: CONSUMER
• Date Received: 2020-03-16
• Date of Report: 2020-03-05
• Date of Event: 2020-02-07
• Date Added to Maude: 2020-03-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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
• Manufacturer Contact: MRS STELLA PIETRAFESA
• Manufacturer Street: 235 E42ND STREET
• Manufacturer City: NEW YORK NY 10017
• Manufacturer Country: US
• Manufacturer Postal: 10017
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Generic Name: DISPOSABLE PACK, HOT
• Product Code: IMD
• Date Received: 2020-03-16
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PFIZER CONSUMER HEALTH CARE
• Manufacturer Address: 1231 WYANDOTTE DRIVE ALBANY GA 31705 US 31705

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2020-03-16