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 Erythema (1840); Skin Erosion (2075); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Event verbatim [preferred term] skin red on two spots [erythema], one spot which looked like a wound [wound] pieces of skin at heatwrap [skin exfoliation], used heatwraps for the back on the skin [intentional device misuse], case narrative:this is a spontaneous report from a contactable pharmacist.An approximately (b)(6) female patient of an unspecified ethnicity 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.On an unspecified date, the patient used heatwraps for the back on the skin and presented with two spots on her back with really red sin and one spot which looked like a wound.It was reported as severe.The reporter stated there were even pieces of skin at the heatwrap.Action taken with the suspect product was unknown.Clinical outcome of the events was 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 erythema, wound, skin exfoliation, and intentional device misuse 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 erythema, wound, skin exfoliation, and intentional device misuse 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] skin red on two spots [erythema], one spot which looked like a wound [wound], pieces of skin at heatwrap [skin exfoliation], used heatwraps for the back on the skin [intentional device misuse].Case narrative:this is a spontaneous report from a contactable pharmacist.An approximately 60-year-old female patient of an unspecified ethnicity 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.On an unspecified date, the patient used heatwraps for the back on the skin and presented with two spots on her back with really red skin and one spot which looked like a wound.It was reported as severe.The reporter stated there were even pieces of skin at the heatwrap.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Per the product quality group: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.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 (23dec2016): follow-up attempts completed.No further information expected.Follow-up (22jan2020): new information received from the product quality group includes investigation summary.Comment: based on the information provided, the reported events erythema, wound, skin exfoliation, and intentional device misuse 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.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 complaint trend for any class(es) associated to the suggested key product complaints database terms.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.No further investigations or actions are suggested at this time.

Manufacturer Narrative

This investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.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.

Manufacturer Narrative

This investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.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] skin red on two spots [erythema] , one spot which looked like a wound [wound] , pieces of skin at heatwrap [skin exfoliation] , used heatwraps for the back on the skin [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.An approximately 60-year-old female patient 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.On an unspecified date, the patient used heatwraps for the back on the skin and presented with two spots on her back with really red skin and one spot which looked like a wound.It was reported as severe.The reporter stated there were even pieces of skin at the heatwrap.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Per the product quality group: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.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) (2016): follow-up attempts completed.No further information expected.Follow-up (b)(6) (2020): new information received from the product quality group includes investigation summary.Amendment: this follow-up report is being submitted to amend previously reported information: mir form updated to correct the sales figures previously submitted in response to the ha query., comment: based on the information provided, the reported events erythema, wound, skin exfoliation, and intentional device misuse 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.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 complaint trend for any class(es) associated to the suggested key product complaints database terms.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.No further investigations or actions are 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: 6066695
• MDR Text Key: 58764757
• Report Number: 1066015-2016-00139
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2016

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/19/2020; 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR