MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Rash (2033); Impaired Healing (2378); Burn, Thermal (2530)

Event Type  Injury  

Event Description

Blisters & rash from thermacare wrap on my stomach/it gave me worse pain on my stomach/feel sick in my stomach/uncomfortable [rash], blisters & rash from thermacare wrap on my stomach/it gave me worse pain on my stomach/feel sick in my stomach/uncomfortable [blister].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), lot number and expiration date not provided, from an unspecified date for back pain.The patient's medical history and concomitant medications were not reported.The patient experienced blisters & rash from thermacare wrap on her stomach/it gave her worse pain on her stomach/feel sick in her stomach/uncomfortable on an unspecified date.Verbatim was as follows: 'i got blisters & rash from thermacare wrap on my stomach.I got product for back pain & it gave me worse pain on my stomach.I honestly feel sick in my stomach.Like sunstroke.It's weird.Very upset about the rash as it looks so unsightly & is very uncomfortable.I think i will have to go to doctor as it is not healing.' the action taken with thermacare heatwrap was unknown.The outcome of the events was not recovered.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "blisters & rash from thermacare wrap on my stomach" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.Comment: based on the information provided, the events of " blisters & rash from thermacare wrap on my stomach" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.

Event Description

Event verbatim [preferred term] blisters & rash from thermacare wrap on my stomach/it gave me worse pain on my stomach/feel sick in my stomach/uncomfortable [rash] , blisters & rash from thermacare wrap on my stomach/it gave me worse pain on my stomach/feel sick in my stomach/uncomfortable [blister].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), lot number and expiration date not provided, from an unspecified date for back pain.The patient's medical history and concomitant medications were not reported.The patient experienced blisters & rash from thermacare wrap on her stomach/it gave her worse pain on her stomach/feel sick in her stomach/uncomfortable on an unspecified date.Verbatim was as follows: 'i got blisters & rash from thermacare wrap on my stomach.I got product for back pain & it gave me worse pain on my stomach.I honestly feel sick in my stomach.Like sunstroke.It's weird.Very upset about the rash as it looks so unsightly & is very uncomfortable.I think i will have to go to doctor as it is not healing.' the action taken with thermacare heatwrap was unknown.The outcome of the events was not recovered.Additional information has been requested and will be provided as it becomes available.Follow-up (11feb2020): this case has been considered invalid as it is a duplicate case.This is a follow-up report combining information from duplicate reports (b)(4).The current and all subsequent follow-up information will be reported under manufacturer report number (b)(4).No follow-up attempts are possible.No further information is expected., comment: based on the information provided, the events of " blisters & rash from thermacare wrap on my stomach" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9671567
• MDR Text Key: 189170029
• Report Number: 1066015-2020-00027
• 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
• Report Date: 01/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention