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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Rupture (2208); Injury (2348); Partial thickness (Second Degree) Burn (2694)

Event Date 01/01/2016

Event Type  Injury  

Event Description

"giant" blister that burst and evolved to wound [burns second degree]."giant" blister that burst and evolved to wound [blister rupture]."giant" blister that burst and evolved to wound [wound].Case description: this is a spontaneous report from a contactable pharmacist, reporting on behalf of a patient's daughter.This (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip, lot number unknown) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On an unspecified date in 2016, the pharmacist reported a patient's daughter applied the heatwrap at 9 am and around lunch time she had "giant" blister on her skin that burst and evolved to wound.The daughter was assisted by the patient's other daughter, who is a nurse.Therapeutic measures taken included unspecified treatment for approximately two weeks and the wound remains opened.Action taken with the suspect product was unknown.Clinical outcome of the events was not resolved.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 "giant" blister that burst and evolved to wound as described in this case are 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.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events of "giant" blister that burst and evolved to wound as described in this case are 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.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Case description: this is a spontaneous report from a contactable pharmacist, reporting on behalf of a patient's daughter.This (b)(6) year-old female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip, lot number unknown) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On an unspecified date in 2016, the pharmacist reported a patient's daughter applied the heatwrap at 9 am and around lunch time she had "giant" blister on her skin that burst and evolved to wound.The daughter was assisted by the patient's other daughter, who is a nurse.Therapeutic measures taken included unspecified treatment for approximately two weeks and the wound remains opened.Action taken with the suspect product 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 ((b)(6) 2016): follow-up attempts completed.No further information expected.Follow-up ((b)(6) 2016): this follow-up is being submitted to notify that an investigation of the device was unable to be conducted.Follow-up attempts have been completed and no further information is expected.Company clinical evaluation comment based on the information provided, the events of "giant" blister that burst and evolved to wound as described in this case are 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.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events of "giant" blister that burst and evolved to wound as described in this case are 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.This case meets final 10-day eu and 30-day fda reportability.

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 was available for evaluation.Without a batch reference number, 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 was made by searching for possible trend for this subclass.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, 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: not received.

Event Description

Event verbatim [preferred term]."giant" blister that burst and evolved to wound [burns second degree], "giant" blister that burst and evolved to wound [blister rupture], "giant" blister that burst and evolved to wound [wound].Narrative: this is a spontaneous report from a contactable pharmacist, reporting on behalf of a patient's daughter.This 64-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip, lot number unknown) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On an unspecified date in 2016, the pharmacist reported the patient's daughter applied the heatwrap at 9 am and around lunch time she had "giant" blister on her skin that burst and evolved to wound.The daughter was assisted by the patient's other daughter, who is a nurse.Therapeutic measures taken included unspecified treatment for approximately two weeks and the wound remains opened.Action taken with the suspect product was unknown.Clinical outcome of the events was not resolved.Per the product quality group: 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 was available for evaluation.Without a batch reference number, 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 was made by searching for possible trend for this subclass.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, 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: not received.Follow-up (26aug2016): follow-up attempts completed.No further information expected.Follow-up (26aug2016): this follow-up is being submitted to notify that an investigation of the device was unable to be conducted.Follow-up attempts have been completed and no further information is expected.Follow-up (01jun2020): new information received from the product quality complaint group includes: investigation results.No follow up attempts possible.No further information is expected.Follow-up (01jun2020): this case is being submitted to notify that the follow-up information previously considered to have been initially received by the company on 18jul2020 was instead received on 01jun2020.No follow up attempts possible.No further information is expected.

• 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: 5815906
• MDR Text Key: 50233031
• Report Number: 1066015-2016-00101
• 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: 07/12/2016

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: 07/12/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: Not provided; 08/26/2016
• Supplement Dates FDA Received: 09/14/2016; 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR