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

Device Problems Leak/Splash (1354); Use of Device Problem (1670)

Patient Problems Caustic/Chemical Burns (2549); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

One leaked [device leakage], burn/second degree burn/chemical burn [burns second degree], burn/second degree burn/chemical burn [chemical burn], i have sciatica and used this on my back.[device use issue].Case narrative: this is a spontaneous report from a pfizer-sponsored program (b)(6) & response program from a non-contactable consumer reporting for self.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date for sciatica.The patient's medical history and concomitant medications were not reported.The patient had sciatica and used this (thermacare) on his/ her back on an unspecified date.When the patient removed it in the evening, the patient had what appeared to be a burn from one of them.Evidently, one leaked, and the patient wouldn't have known until he/she removed it.The patient commented that it was like a second degree burn, "i guess it's a chemical burn." the patient was close to going to the doctor.The action taken with thermacare in response to the event and the event outcome were not reported.According to product quality complaints: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events second degree burn, chemical burn" and device leakage are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported device leakage is a single potential device malfunction which has a theoretical risk to cause skin burn.The event device use issue was assessed as non-serious.A causal relationship between the device and the events cannot be ruled out., comment: based on the information provided, the events second degree burn, chemical burn" and device leakage are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported device leakage is a single potential device malfunction which has a theoretical risk to cause skin burn.The event device use issue was assessed as non-serious.A causal relationship between the device and the events cannot be ruled out.

Manufacturer Narrative

There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis.Site sample status: not received.Final confirmation status: not confirmed.This investigation was conducted for an unknown lot number lower back/hip (lbh) 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 heat cells damaged/leaking.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] one leaked [device leakage] , burn/second degree burn/chemical burn [burns second degree] , burn/second degree burn/chemical burn [chemical burn] , i have sciatica and used this on my back.[device use issue] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program amazon vine review & response program from a non-contactable consumer reporting for self.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date for sciatica.The patient's medical history and concomitant medications were not reported.The patient had sciatica and used this (thermacare) on his/ her back on an unspecified date.When the patient removed it in the evening, the patient had what appeared to be a burn from one of them.Evidently, one leaked, and the patient wouldn't have known until he/she removed it.The patient commented that it was like a second degree burn, "i guess it's a chemical burn." the patient was close to going to the doctor.The action taken with thermacare in response to the event and the event outcome were not reported.According to product quality complaints: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis.Site sample status: not received.Final confirmation status: not confirmed.This investigation was conducted for an unknown lot number lower back/hip (lbh) 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 heat cells damaged/leaking.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)): new information received from a product quality complaint group includes: investigation results.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment: based on the information provided, the events second degree burn, chemical burn" and device leakage are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported device leakage is a single potential device malfunction which has a theoretical risk to cause skin burn.The event device use issue was assessed as non-serious.A causal relationship between the device and the events 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/complaint related trend identified.No further investigations or actions is suggested at this time., comment: based on the information provided, the events second degree burn, chemical burn" and device leakage are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported device leakage is a single potential device malfunction which has a theoretical risk to cause skin burn.The event device use issue was assessed as non-serious.A causal relationship between the device and the events 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/complaint related trend identified.No further investigations or actions is suggested at this time.

Manufacturer Narrative

(b)(6) 2020: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn per rpt # hazard analysis.Site sample status: not received.Final confirmation status: not confirmed.This investigation was conducted for an unknown lot number lower back/hip (lbh) 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 heat cells damaged/leaking.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.(b)(6) 2020: reasonably suggest device malfunction was no and severity of harm was not applicable.

Event Description

Event verbatim [preferred term].Burn/second degree burn/chemical burn [burns second degree], burn/second degree burn/chemical burn [chemical burn], one leaked [device leakage], i have sciatica and used this on my back.[device use issue].Narrative: this is a spontaneous report from the pfizer-sponsored program amazon vine review & response program from a non-contactable consumer reporting for self.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date for sciatica.The patient's medical history and concomitant medications were not reported.The patient had sciatica and used this (thermacare) on his/ her back on an unspecified date.When the patient removed it in the evening, the patient had what appeared to be a burn from one of them.Evidently, one leaked, and the patient wouldn't have known until he/she removed it.The patient commented that it was like a second degree burn, "i guess it's a chemical burn." the patient was close to going to the doctor.The action taken with thermacare in response to the events and the events outcome were not reported.According to the product quality complaint group on (b)(6) 2020: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn per rpt # hazard analysis.Site sample status: not received.Final confirmation status: not confirmed.This investigation was conducted for an unknown lot number lower back/hip (lbh) 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 heat cells damaged/leaking.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.According to the product quality complaint group on (b)(6) 2020: reasonably suggest device malfunction was no and severity of harm was not applicable.Follow-up (08jan2020): new information received from a product quality complaint group includes: investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (18jul2020): new information received from the product quality complaint group included: updated reasonably suggest device malfunction and severity of harm.Follow-up (05apr2020): 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 05apr2020.No follow up attempts are possible.No further information is expected.Comment: based on the information provided, the events second degree burn, chemical burn" and device leakage are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported device leakage is a single potential device malfunction which has a theoretical risk to cause skin burn.The event device use issue was assessed as non-serious.A causal relationship between the device and the events 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/complaint related trend identified.No further investigations or actions 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: 9603996
• MDR Text Key: 189163560
• Report Number: 1066015-2020-00005
• 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: 01/01/2020

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: 01/17/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/04/2020; 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention