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 Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Thermal burns on his back [thermal burn], wore the thermacare backbelt overnight [device use error].Case narrative: this is a spontaneous report from a contactable consumer through the pfizer-sponsored program, thermacare brand purpose focus groups (b)(4).A (b)(6) male patient started to use thermacare heatwrap (thermacare lower back & hip, lot number and expiration date not provided) on an unspecified date for unspecified indication.The patient medical history and concomitant medications were not provided.The reporter's friend wore the thermacare backbelt overnight and had thermal burns on his back.The action taken in response to the event with thermacare heatwrap was permanently withdrawn on an unknown date.The event outcome was unknown.The reporter considered the event as non-serious and related to thermacare.Additional information has been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 and device use error 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.Comment: based on the information provided, the events of burns second degree and device use error 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.

Event Description

Event verbatim [preferred term] thermal burns on his back [thermal burn] , wore the thermacare backbelt overnight [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer through the pfizer-sponsored program, thermacare brand purpose focus groups germany.A 63-year-old male patient started to use thermacare heatwrap (thermacare lower back & hip, lot number and expiration date not provided) on an unspecified date for unspecified indication.The patient medical history and concomitant medications were not provided.The reporter's friend wore the thermacare backbelt overnight and had thermal burns on his back.The action taken in response to the event with thermacare heatwrap was permanently withdrawn on an unknown date.The event outcome was unknown.The reporter considered the event as non-serious and related to thermacare.According to product quality group: albany 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 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/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: severity of harm is s3.A full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient sustained a burn injury with product use.Review of complaint description concludes there is no device malfunction.Follow-up (18dec2019 and 20dec2019): new information received from product quality group includes: severity and malfunction assessment from dchu; investigation results from division albany received on 20dec2019.Company clinical evaluation comment: based on the information provided, the events of burns second degree and device use error 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 remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the events of burns second degree and device use error 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 remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Albany 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 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/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.

• 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: 9511940
• MDR Text Key: 188816324
• Report Number: 1066015-2019-00555
• 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
• Report Date: 12/12/2019

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR