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

Device Problem Product Quality Problem (1506)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Burn on back [thermal burn].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported "i bought the thermacare for the back and now i experienced a burn on my back.I can give you a photo to show the burn.I have severe pain." action taken with the suspect product was unknown.Clinical outcome of the event was unknown.According to product quality complaint (pqc) group: severity of harm: s3.Dchu conclusion: a summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient sustained a burn injury with product use.Review of complaint description concludes there is no device malfunction.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/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.Follow-up (25nov2019 and 26nov2019): new information from product quality complaint group included: severity of harm, investigation results, and case upgraded to a serious malfunction reportable mdr.Company clinical evaluation comment: based on the information provided, the event of "burn on my back" as described 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.Comment: based on the information provided, the event of "burn on my back" as described 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.

• 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
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 9417665
• MDR Text Key: 187210393
• Report Number: 1066015-2019-00518
• 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,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2019

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: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention