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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Tissue Damage (2104)

Event Date 05/01/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] i had it on for about 9 hours [device use error] , deep open bleeding sore [wound haemorrhage] , 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), via an unspecified route of administration from an unspecified date indicated for pain.The patient medical history and concomitant medications were not reported.On (b)(6) 2019 the patient wore a thermacare wrap on her lower back and reported have used them a few times without any problem even in the past for many hours over the intended time by accident, at the time of the report she had it on for about 9 hours and experienced quite a deep open bleeding sore.It started as a painful spot type lesion when she removed the wrap and has deepened into the sore.She had become aware that sheet was wet from perspiration under the wrap and a few areas felt irritated and sore and when she removed it, saw a few small lesions.One felt very painful.The patient put plasters on them and at the time of the report, and one of them looked quite bad.The action taken with thermacare heatwrap was unknown.The outcomes 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 events of "device use error" and "wound haemorrhage" as described are considered serious bodily injury 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., comment: based on the information provided, the events of "device use error" and "wound haemorrhage" as described are considered serious bodily injury 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.

Event Description

Event [preferred term] deep open bleeding sore [wound haemorrhage] , i had it on for about 9 hours [device use error] ,.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) (device lot number not reported) from an unspecified date indicated for pain.The patient's medical history and concomitant medications were not reported.On (b)(6) 2019 the patient wore a thermacare wrap on her lower back and reported have used them a few times without any problem even in the past for many hours over the intended time by accident.She had it on for about 9 hours and experienced quite a deep open bleeding sore.It started as a painful spot type lesion when she removed the wrap and has deepened into the sore.She had become aware that sheet was wet from perspiration under the wrap and a few areas felt irritated and sore.When she removed it, she saw a few small lesions.One felt very painful.The patient put plasters on them and at the time of the report, and one of them looked quite bad.Upon follow-up received on 13may2019, the patient reported the heatwrap was not visibly damaged, so she does not know why it injured her like that.She was still using burn dressings, but was now allergic to the burn dressings so she had nothing to cover the wound.She stated the event was not resolved.Action taken with thermacare heatwrap was unknown.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (on (b)(6) 2019): new information received from a contactable consumer includes: event outcome.Company clinical evaluation comment: based on the information provided, the events of "device use error" and "wound haemorrhage" as described are considered serious bodily injury 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., comment: based on the information provided, the events of "device use error" and "wound haemorrhage" as described are considered serious bodily injury 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.

Manufacturer Narrative

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 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] she was still using burn dressings [thermal burn] , deep open bleeding sore [wound haemorrhage] , i had it on for about 9 hours [device use error] ,.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) (device lot number not reported) from an unspecified date indicated for pain.The patient's medical history and concomitant medications were not reported.On (b)(6) 2019 the patient wore a thermacare wrap on her lower back and reported have used them a few times without any problem even in the past for many hours over the intended time by accident.She had it on for about 9 hours and experienced quite a deep open bleeding sore in (b)(6) 2019.It started as a painful spot type lesion when she removed the wrap and has deepened into the sore.She had become aware that sheet was wet from perspiration under the wrap and a few areas felt irritated and sore.When she removed it, she saw a few small lesions.One felt very painful.The patient put plasters on them and at the time of the report, and one of them looked quite bad.Upon follow-up received on (b)(6) 2019, the patient reported the heatwrap was not visibly damaged, so she does not know why it injured her like that.She was still using burn dressings (onset date (b)(6) 2019), but was now allergic to the burn dressings so she had nothing to cover the wound.She stated the event was not resolved.Action taken with thermacare heatwrap was unknown.Clinical outcome of the events was not resolved.According to product quality complaint group: 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 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 ((b)(6) 2019): new information received from a contactable consumer includes: event outcome.Follow-up (17jul2019): new information received from product quality complaint group included: investigation results and adding additional event (she was still using burn dressings)., comment: based on the information provided, the events of thermal burn, wound haemorrhage and device use error as described are considered serious bodily injury 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.In the case narrative, there is evidence of device use error which most likely contributed to this incident.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
• MDR Report Key: 8608180
• MDR Text Key: 145090405
• Report Number: 1066015-2019-00148
• 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,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• 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