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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Contusion (1787); Scarring (2061); Discomfort (2330); Burn, Thermal (2530)

Event Date 08/01/2014

Event Type  Injury  

Event Description

Marks/permanent scar on back [scar].Burns on back/suffered burns [thermal burn].Bruises/marks on back [contusion].Soreness [discomfort].Case description: this is a spontaneous report from a contactable consumer or other non-hcp.A (b)(6) male patient of unspecified ethnicity started using (b)(6) heatwrap ((b)(6) lower back and hip) since an unknown date at an unknown frequency for an unknown indication.Relevant medical history and concomitant medication were unknown.It was reported that since an unknown date the patient experienced burns, soreness and marks/bruises on his back while using the heatwrap.The reporter stated they followed the instruction on the box.Relevant laboratory data was unknown.The last action taken with the heatwrap was unknown.Therapeutic measures taken in response to the reported event included unspecified treatment.Clinical outcome of the reported events was unknown at the time of report.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2014): follow-up attempts completed.No further information expected.Follow-up ((b)(6) 2015): new information received from contactable consumer includes: therapeutic measures taken and additional event of discomfort.Follow-up ((b)(6) 2015): follow-up attempts completed.No further information expected.Follow-up ((b)(6) 2015): this contactable consumer reported by way of consumer questionnaire.This (b)(6), male patient started to use (b)(6) heatwrap ((b)(6) lower back and hip) one patch once daily for 2-3 hours at most for approximately 3 days in (b)(6) 2014 for lower back pain.He applied the product directly to skin and checked frequently during usage.On third day of his use in (b)(6) 2014, he suffered burns, soreness, breaking of the skin, bruises on back and burned his back and left marks/permanent scar on back.It was reported that he still experiencing marks/permanent scar on back.He discontinued the usage of product in (b)(6) 2014.On an unknown date, he received unknown treatment for burns.On an unknown date, he was hospitalized for marks/permanent scar on back.As of (b)(6) 2015, the clinical outcome of the event marks/permanent scar on back was not recovered.

Event Description

Event verbatim [preferred term].Marks/permanent scar on back [scar], burns on back/suffered burns [thermal burn], bruises/marks on back [contusion], soreness [discomfort].Narrative: this is a spontaneous report from a contactable consumer or other non-healthcare professional.A 13 year old male patient started using thermacare heatwrap (thermacare lower back & hip) at one patch once daily for 2-3 hours at most for approximately 3 days in (b)(6) 2014 for lower back pain.Relevant medical history and concomitant medication were unknown.It was reported that since an unknown date the patient experienced burns, soreness and marks/bruises on his back while using the heatwrap.He applied the product directly to skin and checked frequently during usage.On third day of his use in (b)(6) 2014, he suffered burns, soreness, breaking of the skin, bruises on back and burned his back and left marks/permanent scar on back.The reporter stated they followed the instructions on the box.Relevant laboratory data was unknown.On an unknown date, he was hospitalized for marks/permanent scar on back.The last action taken with thermacare heatwrap was discontinued in (b)(6) 2014.Therapeutic measures taken in response to the reported event included unspecified treatment.It was reported that he still experiencing (not recovered) from marks/permanent scar on back.Clinical outcome of all other events was unknown at the time of report.Product investigation results were as follows: other trend assessment & rationale: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage and investigation (citi) search was performed.Scope: date contacted: (b)(6) 2011 through (b)(6) 2014.Manufacturing site: pfizer albany/complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation.The citi search returned a total 37 complaints for the lower back and hip (lbh) products during this time period for the class/subclass adverse event safety request for investigation.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclass shows a seasonality increase in complaints for (b)(6) 2012.A citi complaint trend search was conducted for the subclass adverse event safety request for investigation for lbh products.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products.There is no further action required.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 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.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status was not received.Follow-up (12oct2014): follow-up attempts completed.No further information expected.Follow-up (09feb2015): new information received from contactable consumer includes: therapeutic measures taken and additional event of discomfort.Follow-up (08apr015): follow-up attempts completed.No further information expected.Follow-up (22may2015): new information from a contactable consumer reported by way of consumer questionnaire includes: patient information (updated age), product information (added doe, units, frequency, start and stop date), reaction data, and hospitalization.Follow-up (17apr2020): new information received from a product quality complaint group includes: product investigation results.Follow-up attempts completed.No further information expected.

Manufacturer Narrative

Other trend assessment & rationale: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage and investigation (citi) search was performed.Scope: date contacted: (b)(6) 2011 through (b)(6) 2014.Manufacturing site: pfizer albany/complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation.The citi search returned a total 37 complaints for the lower back and hip (lbh) products during this time period for the class/subclass adverse event safety request for investigation.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclass shows a seasonality increase in complaints for (b)(6) 2012.A citi complaint trend search was conducted for the subclass adverse event safety request for investigation for lbh products.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products.There is no further action required.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 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.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status was not received.

• 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: 4814971
• MDR Text Key: 5895711
• Report Number: 1066015-2015-00061
• 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,consumer
• Type of Report: Initial,Followup
• Report Date: 08/19/2014

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: 05/22/2015
• Initial Date FDA Received: 06/01/2015
• Supplement Dates Manufacturer Received: 05/22/2015
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 13 YR