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

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problems Pain (1994); Tissue Damage (2104); Burn, Thermal (2530)

Event Type  Injury  

Event Description

The wrap burned my stomach [thermal burn], the skin peeled off [skin exfoliation], the wrap layed over on to my lower stomach [device use error].Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age, ethnicity and gender started to use thermacare heatwrap (thermacare lower back and hip) from an unspecified date for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient reported "i used the lower back/hip pain wrap on my upper hip.Part of the wrap layed over on to my lower stomach.Well to my surprise the wrap burned my stomach and the skin peeled off! i've used this product on numerous occasions with no problems.Please advise how i can submit information for a refund and i doubt i'll use the other wraps that are left." on an unspecified date.Action taken in response to the event for thermacare heatwrap was unknown.The outcome of the events were unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the reported events thermal burn, skin exfoliation, and device use error as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] the wrap burned my stomach [thermal burn] , the skin peeled off [skin exfoliation] , the wrap laid over on to my lower stomach [device use error] , case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age, ethnicity and gender started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient reported "i used the lower back/hip pain wrap on my upper hip.Part of the wrap laid over on to my lower stomach.Well to my surprise the wrap burned my stomach and the skin peeled off! i've used this product on numerous occasions with no problems." the onset date of events was unknown.Treatment was received for the events (unspecified).Action taken in response to the event for thermacare heatwrap was unknown.The outcome of the events was unknown.Upon follow up the patient did not purchase the product through advice or prescription from the hcp.The patient did not see the hcp for the injury.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2017): new information received from a contactable consumer included treatment (unspecified) and the patient did not see an hcp regarding the events.No follow-up attempts are possible.An investigation of the device could not be conducted.Company clinical evaluation comment based on the information provided, the reported events thermal burn, skin exfoliation, and device use error as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device., comment: based on the information provided, the reported events thermal burn, skin exfoliation, and device use error as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.

Event Description

Event verbatim [preferred term] the wrap layed over on to my lower stomach [device use error], the wrap burned my stomach [thermal burn], the skin peeled off [skin exfoliation], , narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient reported "i used the lower back/hip pain wrap on my upper hip.Part of the wrap layed over on to my lower stomach.Well to my surprise the wrap burned my stomach and the skin peeled off! i've used this product on numerous occasions with no problems." the onset date of events was unknown.Treatment was received for the events (unspecified).Action taken in response to the event for thermacare heatwrap was unknown.The outcomes of the events were unknown.Upon follow up the patient did not purchase the product through advice or prescription from the hcp.The patient did not see the hcp for the injury.According to product complaint group: site had not received the sample.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up (01feb2017): new information received from a contactable consumer included treatment (unspecified) and the patient did not see an hcp regarding the events.No follow-up attempts are possible.An investigation of the device could not be conducted.Follow-up (20jun2017): follow-up attempts are completed.No further information is expected.Follow-up (01jun2020): new information received from product complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.

• 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: 6282418
• MDR Text Key: 65922174
• Report Number: 1066015-2017-00013
• 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: 01/20/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/06/2017; 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention