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

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Event verbatim [preferred term] burn with blisters with fluid in blisters [burns second degree].Case narrative:this is a spontaneous report from a contactable other hcp.An adult female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare menstrual) (device lot number not available) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the reporter stated an adult female patient bought the menstrual wraps in the pharmacy and experienced burn with blisters with fluid in blisters.Action taken with the suspect product was unknown.Therapeutic measures taken included unspecified treatment.Clinical 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 of "burn with blisters with fluid in blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event of "burn with blisters with fluid in blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Manufacturer Narrative

This investigation was conducted for an unknown lot number menstrual 8 hour product.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 trend identified related for the subclass adverse event safety request for investigation.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.

Event Description

Event verbatim [preferred term] burn with blisters with fluid in blisters [burns second degree], narrative: this is a spontaneous report from a contactable other hcp.An adult female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare menstrual) (device lot number not available) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the reporter stated an adult female patient bought the menstrual wraps in the pharmacy and experienced burn with blisters with fluid in blisters.Action taken with the suspect product was unknown.Therapeutic measures taken included unspecified treatment.Clinical outcome of the event was unknown.Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.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 trend identified related for the subclass adverse event safety request for investigation.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.The citi customizable search returned a total of 82 complaints for menstrual 8hr products during this time period for the class/subclass.One of the 82 was confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Summary of the confirmed complaint is as follows: investigations (b)(4) for batch t26693: this investigation was related to investigation (b)(4).(b)(4) determined the most probable root cause of the event is equipment/other with method as a contributory factor.The root cause is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because a manufacturing work instruction (mwi) document for purging brine is necessary.There is not a document that clearly provides instructions on how to purge brine.Follow-up (16apr2018) follow-up attempts completed.No further information expected.Follow-up (16jun2020): new information received from product quality includes: investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event of "burn with blisters with fluid in blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

• 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: 7290666
• MDR Text Key: 100766991
• Report Number: 1066015-2018-00026
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

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: Not provided
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention