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

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

Her thigh has damage [limb injury], she's hurting [pain in extremity], used the product on her thigh [intentional device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date at an unspecified frequency for soothe and stop the pain.The patient medical history and concomitant medications were not reported.The consumer was calling about thermacare back and body aches (as reported), and reads on the product for arthritis, joint pain, and sore muscles.The patient used the product on her thigh and states now her thigh has damage.She's hurting.She kept using it.The action taken with thermacare heatwrap in response the event and outcome of the event were unknown.Additional information received from product quality complaint (pqc) group included: severity of harm: s3.Additional information has been requested and will be provided as it becomes available.Follow-up (19nov2019): new information received from the product quality complaints group included: severity rating, and case upgraded to a serious, malfunction, reportable mdr.Amendment: this report is being submitted to amend suspect device from thermacare menstrual to thermacare lower back & hip.Company clinical evaluation comment: based on the information provided, the events limb injury and pain in extremity as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] her thigh has damage [limb injury] , she's hurting [pain in extremity] , used the product on her thigh [intentional device use issue].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date at an unspecified frequency for soothe and stop the pain.The patient medical history and concomitant medications were not reported.The consumer was calling about thermacare back and body aches (as reported), and reads on the product for arthritis, joint pain, and sore muscles.The patient used the product on her thigh and states now her thigh had damage.She's hurting.She kept using it.The action taken with thermacare heatwrap in response the event was dose not hanged.The outcome of the event were unknown.Additional information received from product quality complaint (pqc) group included: severity of harm: s3.Summary of investigation: a summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient sustained a thigh injury with product use.Whether medical intervention was necessary was not reported.Review of complaint description concludes there is no device malfunction.Site sample status was not received.Additional information has been requested and will be provided as it becomes available.Follow-up (19nov2019): new information received from the product quality complaints group included: severity rating, and case upgraded to a serious, malfunction, reportable mdr.Amendment: this report is being submitted to amend suspect device from thermacare menstrual to thermacare lower back & hip.Follow-up (02jan2020): follow-up attempts are completed.No further information is expected.Follow-up (21nov2019): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events limb injury and pain in extremity as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.A causal relationship between the device and events cannot be ruled out., comment: based on the information provided, the events limb injury and pain in extremity as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.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: 9417664
• MDR Text Key: 186405257
• Report Number: 1066015-2019-00508
• 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: 10/28/2019

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
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention