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

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Got burned by the pack/huge blister across my back [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back and hip), from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient stated "i used the thermacare heat wrap on my lower back.I have never used your particular brand before but usually use another brand.I wanted you to know that i got burned by the pack and have a huge blister across my back.I would like to share a picture with you of it.It's fairly graphic." the action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event 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 events of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the events of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Event Description

Got burned by the pack/huge blister across my back [burns second degree] ,.Case narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back and hip), from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient stated "i used the thermacare heat wrap on my lower back.I have never used your particular brand before but usually use another brand.I wanted you to know that i got burned by the pack and have a huge blister across my back.I would like to share a picture with you of it.It's fairly graphic." the patient further stated that "further is didn't go to the dr over a burn.As unfit.Let me share a pic of the burn site from today.It's healing".The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was resolving.Additional information has been requested and will be provided as it becomes available.Follow-up (28aug2018): new information received from the same contactable consumer includes: event outcome.Company clinical evaluation comment: based on the information provided, the events of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the events of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term].Got burned by the pack/huge blister across my back [burns second degree].Narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient stated "i used the thermacare heat wrap on my lower back.I have never used your particular brand before but usually use another brand.I wanted you to know that i got burned by the pack and have a huge blister across my back.I would like to share a picture with you of it.It's fairly graphic." the patient further stated that "further is didn't go to the dr over a burn.As unfit.Let me share a pic of the burn site from today.It's healing".The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was resolving.According to product complaint 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.There was no reasonably suggest device malfunction.Follow-up (28aug2018): new information received from the same contactable consumer includes: event outcome.Follow-up (28mar2019): follow-up attempts are completed.No further information is expected.Follow up (17apr2020): new information received from a product complaint group included: investigation result.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.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.There is not a product quality related trend identified.No further investigations or actions is 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.There was no reasonably suggest device malfunction.

• 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: 7813154
• MDR Text Key: 118153250
• Report Number: 1066015-2018-00096
• 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: 08/20/2018

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: 08/24/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/31/2018; 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention