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

Lot Number	AR5202
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)
Health Effect - Clinical Code	Sweating (2444)
Type of Reportable Event	Malfunction
Event or Problem Description
Gets so hot she would sweat [hyperhidrosis],the one for the back she used got really hot; works so good and gets so hot she would sweat [device issue].Narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ar5202, expiration date may2022, udi number (b)(4), via an unspecified route of administration from an unspecified date at unknown frequency for her hip.The patient medical history and concomitant medications were not reported.The patient reported she bought 8 box of the big ones that went around the waist and those would get so hot they would sweat.The one for the back she used got really hot, she used it for her hip.She went on to explain that one worked so good and got so hot she would sweat.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.
Event or Problem Description
Event verbatim [preferred term]: one worked so good and got so hot she would sweat [no adverse event], narrative: this case was made invalid since there is no indication the consumer experienced an adverse event under thermacare.This is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ar5202, expiration date may2022, udi number (b)(4), via an unspecified route of administration from an unspecified date at unknown frequency for her hip.The patient medical history and concomitant medications were not reported.The patient reported she bought 8 box of the big ones that went around the waist and those would get so hot they would sweat.The one for the back she used got really hot, she used it for her hip.She went on to explain that one worked so good and got so hot she would sweat.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Follow-up (12nov2020): follow-up attempts completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: case reassessed as invalid, does not meet the definition of a medical device complaint and was not considered a malfunction.

• Brand Name: THERMACARE LOWER BACK & HIP
• Common Device Name: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 10755158
• Report Number: 1066015-2020-00181
• Device Sequence Number: 3570402
• Product Code: IMD
• UDI-Device Identifier: 00305733010020
• UDI-Public: 305733010020
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/01/2022
• Device Lot Number: AR5202
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1