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

Device Problems Loss of or Failure to Bond (1068); Product Quality Problem (1506)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Manufacturer Narrative

This investigation was conducted for an unknown lot number of lower back/hip (lbh).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 and/or return sample 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/serious/unknown.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

The heat was pathetic in one box of them and the other burned my skin [thermal burn], the velcro or whatever it is made of is so cheap i had to tie the stupid thing in knot to keep it from coming off.[device use error].Case narrative: this is a spontaneous report from a contactable consumer via pfizer-sponsored program thermacare power reviews.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported the velcro or whatever it was made of was so cheap the patient had to tie the stupid thing in knot to keep it from coming off on an unspecified date.The heat was pathetic in one box of them and the other burned his/her skin on an unspecified date.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Manufactory site conclusion: this investigation was conducted for an unknown lot number of lower back/hip (lbh).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 and/or return sample 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/serious/unknown.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.Dchu conclusion: based on the complaint narrative, the patient sustained a burn injury after product use.Review of complaint description concludes there is no device malfunction.Severity of harm was assessed as s3 for complaint sub-class: adverse event / serious / unknown.Follow-up (26aug2019): follow-up attempts are completed.No further information is expected.Follow-up (27aug2019, 31aug2019 and 17oct2019): new information received from product quality complaint group included: investigation results from manufactory site and dchu malfunction and severity assessment.This case is upgraded to a reportable mdr.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events thermal burn, device use error and device issue 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.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the events thermal burn, device use error and device issue 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.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

• 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
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 9444785
• MDR Text Key: 187708870
• Report Number: 1066015-2019-00536
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention