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

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Event verbatim [preferred term] burn: slight oval 3-4 cm, also a burn blister, very painful [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable health care professional (pharmaceutical technical assistant) via customer care center.A female patient (approximately (b)(6)) of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) from (b)(6) 2016 for back pain.Only one wrap was used.The patient's medical history was not reported.There were no concomitant medications.On an unspecified date, the patient reported a burn: slight oval 3-4 cm, also a burn blister, very painful.Action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2016.Clinical outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Company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 reported event burn blister as described in this case is considered serious bodily injury 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 event burn blister as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.

Manufacturer Narrative

This investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.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 trend identified related for the subclass adverse event safety request for investigation.Root cause category was non-assignable (complaint not confirmed).Site sample status was not received.

Event Description

Event verbatim [preferred term] burn: slight oval 3-4 cm, also a burn blister, very painful [burns second degree].Case narrative:this is a spontaneous report from a contactable health care professional (pharmaceutical technical assistant) via customer care center.A female patient (approximately 90-years-old) started to use thermacare heatwrap (thermacare lower back & hip) from (b)(6) 2016 for back pain.Only one wrap was used.The patient's medical history was not reported.There were no concomitant medications.On an unspecified date, the patient reported a burn: slight oval 3-4 cm, also a burn blister, very painful.Action taken in response to the events for thermacare heatwrap was permanently withdrawn on 05dec2016.Clinical outcome of the event was unknown.Product quality information provided the following: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.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 trend identified related for the subclass adverse event safety request for investigation.Root cause category was non-assignable (complaint not confirmed).Site sample status was not received.Follow-up (03feb2017): follow-up attempts completed.No further information expected.Follow-up (07feb2020): new information received from pfizer product quality group includes investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the reported event burn blister as described in this case is considered serious bodily injury 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.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 reported event burn blister as described in this case is considered serious bodily injury 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.Product effect varies with each individual.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: 6169287
• MDR Text Key: 62313093
• Report Number: 1066015-2016-00165
• 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
• Report Date: 12/07/2016

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: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR