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 Pain (1994); Swelling (2091); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

I have about six burns on my lower back that blistered up with water/in so much pain [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), unknown lot number and expiration date, from an unspecified date for an unspecified indication.Medical history and concomitant medications were not reported.The patient reported that there are about six burns on their lower back that blistered up with water and was in so much pain on an unspecified date.Thermacare heatwrap was used for less than 8 hours.The action taken with thermacare heatwrap and the 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 event burns second degree is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.Comment: based on the information provided, the event burns second degree is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.

Event Description

Event verbatim [preferred term] i have about six burns on my lower back that blistered up with water/in so much pain [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), unknown lot number and expiration date, from an unspecified date for an unspecified indication.Medical history and concomitant medications were not reported.The patient reported that there are about six burns on their lower back that blistered up with water and was in so much pain on an unspecified date.Thermacare heatwrap was used for less than 8 hours.The action taken with thermacare heatwrap and the outcome of the event was unknown.According to the product quality complaint group: this investigation was conducted for an unknown lot number of 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 adverse event safety/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.A lot trend was not performed as the lot number is unknown.Site sample status is not received.Severity of harm is s3.Follow-up (28feb2020 and 07mar2020): new information received from product quality complaint group includes investigation results., comment: based on the information provided, the event burns second degree is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event 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.No further investigations or actions is suggested at this time.

Manufacturer Narrative

This investigation was conducted for an unknown lot number of 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 adverse event safety/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.A lot trend was not performed as the lot number is unknown.Site sample status is not received.Severity of harm is s3.

• 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: 9637289
• MDR Text Key: 189166484
• Report Number: 1066015-2020-00017
• 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
• Report Date: 01/04/2020

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: 01/28/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention