MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

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

Patient Problems Scarring (2061); Burn, Thermal (2530)

Event Type  Injury  

Event Description

Acquired a burn from one of these wraps [thermal burn], did anticipate it leaving a scar [scar], was wondering if the product was may be defective [device defective], , narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unknown age started to use thermacare heatwrap (thermacare menstrual) on an unknown date over 5 years before the report time monthly to help with her severe cramps.Relevant medical history and concomitant medications were not provided.The patient had been using these wraps monthly for years and she absolutely swore by them.However, for the first time, she acquired a burn from one of these wraps and was wondering if the product was may be defective.She would be happy to send photo proof if necessary but just wanted to contact pfizer as she had never experienced this in over 5 years of consistently using them.She was contacting to make pfizer aware of this problem and to prevent anyone else from experiencing this as well.It of course could have been a lot worse and she hated to complain but she did anticipate it leaving a scar.It was worth noting and making pfizer aware.The action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.Additional information has been requested and will be provided as it becomes available.

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/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.Reasonably suggest device malfunction: yes; severity of harm: n/a; site sample status: not received.

Event Description

Event verbatim [preferred term], acquired a burn from one of these wraps [thermal burn], did anticipate it leaving a scar [scar], was wondering if the product was may be defective [device defective], narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unknown age started to use thermacare heatwrap (thermacare menstrual) on an unknown date over 5 years before the report time monthly to help with her severe cramps.Relevant medical history and concomitant medications were not provided.The patient had been using these wraps monthly for years and she absolutely swore by them.However, for the first time, she acquired a burn from one of these wraps and was wondering if the product was may be defective.She would be happy to send photo proof if necessary but just wanted to contact pfizer as she had never experienced this in over 5 years of consistently using them.She was contacting to make pfizer aware of this problem and to prevent anyone else from experiencing this as well.It of course could have been a lot worse and she hated to complain but she did anticipate it leaving a scar.It was worth noting and making pfizer aware.The action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.Product quality complaints reports that: 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/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.Rsnbly suggest device malfunction: yes; severity of harm: n/a; site sample status: not received.Follow-up (11jun2020): follow-up attempts completed.No further information expected.Follow-up (22jun2020): new information received from product quality complaints includes: investigation results.Follow-up attempts are completed.No further information is expected.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 10054194
• MDR Text Key: 190922086
• Report Number: 1066015-2020-00115
• 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: 05/05/2020

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: 05/13/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention