MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Event Description

Thinks she is allergic to thermacare [device allergy], both hands are stinging after applying thermacare [pain], leg where thermacare was applied is stinging [application site pain].Case narrative: this is a spontaneous report from a contactable consumer.This female consumer of unknown age started to receive thermacare heatwrap (thermacare heatwrap) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for leg cramp.Medical history and concomitant medications were not reported.Consumer thought she was allergic to thermacare.She had leg cramps and the thermacare seemed to work on that.The hand she used to apply the thermacare stung.She washed her hands, but her hand was still stinging from where she touched the thermacare.Consumer asked what ingredient in the thermacare should she consider was the problem.She was assuming the stinging will eventually wear off.She wanted to know if there was something she could do for the stinging.She stated both hands and the leg where she applied the thermacare were stinging.She took a shower, but her hands and leg were still stinging.She wanted to find out more about thermacare and what possibly could be causing this.She stated she had leg cramps often and had used other things that didn't bother her.She was just going to throw the thermacare away.She wanted to know what to do to make the stinging go away.The action taken in response to the events of the product was permanently withdrawn on unknown date.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Comment: based on the information provided, the events device allergy, pain and application site pain as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Event Description

Thinks she is allergic to thermacare [drug hypersensitivity] both hands are stinging after applying thermacare [pain] leg where thermacare was applied is stinging [application site pain] case description: this is a spontaneous report from a contactable consumer.This female consumer of unknown age started to receive camphor, capsaicin, menthol, methyl salicylate (thermacare ultra,previously coded to thermacare heatwrap) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for leg cramp.Medical history and concomitant medications were not reported.Consumer thought she was allergic to thermacare.She had leg cramps and the thermacare seemed to work on that.The hand she used to apply the thermacare stung.She washed her hands, but her hand was still stinging from where she touched the thermacare.Consumer asked what ingredient in the thermacare should she consider was the problem.She was assuming the stinging will eventually wear off.She wanted to know if there was something she could do for the stinging.She stated both hands and the leg where she applied the thermacare were stinging.She took a shower, but her hands and leg were still stinging.She wanted to find out more about thermacare and what possibly could be causing this.She stated she had leg cramps often and had used other things that didn't bother her.She was just going to throw the thermacare away.She wanted to know what to do to make the stinging go away.The action taken in response to the events of the product was permanently withdrawn on unknown date.The outcome of the events was unknown.Follow-up (b)(6) 2020: new information received from product quality complaint group is to clarify that it has been identified and determined that the product in question is the thermacare cream and not the thermacare heat wrap.The case now changed to non-serious.Follow-up attempts are completed.No further information is expected.Comment: based on the information provided, the events device allergy, pain and application site pain as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] thinks she is allergic to thermacare [drug hypersensitivity], both hands are stinging after applying thermacare [pain], leg where thermacare was applied is stinging [application site pain].Narrative: this is a spontaneous report from a contactable consumer.This female consumer of unknown age started to receive camphor, capsaicin, menthol, methyl salicylate (thermacare ultra,previously coded to thermacare heatwrap) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for leg cramp.Medical history and concomitant medications were not reported.Consumer thought she was allergic to thermacare.She had leg cramps and the thermacare seemed to work on that.The hand she used to apply the thermacare stung.She washed her hands, but her hand was still stinging from where she touched the thermacare.Consumer asked what ingredient in the thermacare should she consider was the problem.She was assuming the stinging will eventually wear off.She wanted to know if there was something she could do for the stinging.She stated both hands and the leg where she applied the thermacare were stinging.She took a shower, but her hands and leg were still stinging.She wanted to find out more about thermacare and what possibly could be causing this.She stated she had leg cramps often and had used other things that didn't bother her.She was just going to throw the thermacare away.She wanted to know what to do to make the stinging go away.The action taken in response to the events of the product was permanently withdrawn on unknown date.The outcome of the events was unknown.Follow-up (02mar2020): new information received from product quality complaint group is to clarify that it has been identified and determined that the product in question is the thermacare cream and not the thermacare heat wrap.The case now changed to non-serious.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to notify us food and drug administration (fda) that mfr report number and mfr report number 1066015-2020-00094 are duplicate.All subsequent follow-up information will be reported under mfr report number 1066015-2020- 00057.Mfr report number 1066015-2020-00094 is to be considered as deleted.Comment: based on the information provided, the events device allergy, pain and application site pain as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9808306
• MDR Text Key: 190337735
• Report Number: 1066015-2020-00057
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2020

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: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 03/02/2020; 02/16/2021
• Supplement Dates FDA Received: 03/31/2020; 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention