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 Unspecified Infection (1930); Swelling (2091)

Event Date 03/29/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] got blisters that popped and became infected [blister infected].Case narrative: this is a spontaneous report from a contactable consumer received from us fda.Regulatory authority report number mw5085794.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), via an unspecified route of administration from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient used a thermacare menstrual heat wrap and got blisters that popped and became infected on (b)(6) 2019.The action taken for the product and event outcome was unknown.The event was assessed as serious injury.

Manufacturer Narrative

Initial complaint assessment: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The pcom search returned a total of 102 complaints for menstrual products during this time period for the class/subclass.There were two complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for menstrual products, refer to the attached trend chart for may2016 - may2019.There is no further action required.Investigation summary: 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.There is not a trend identified for the subclass of adverse event safety request for investigation for menstrual products, refer to the attached trend chart for may2016 - may2019.There is no further action required.

Event Description

Event verbatim [preferred term] got blisters that popped and became infected [blister infected].Case narrative:this is a spontaneous report from a contactable consumer received from us fda.Regulatory authority report number mw (b)(4).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), via an unspecified route of administration from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient used a thermacare menstrual heat wrap and got blisters that popped and became infected on (b)(6) 2019.The action taken for the product and event outcome was unknown.The event was assessed as serious injury.According to product quality complaint group: initial complaint assessment: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The pcom search returned a total of 102 complaints for menstrual products during this time period for the class/subclass.There were two complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for menstrual products, refer to the attached trend chart for may2016 - may2019.There is no further action required.Investigation summary: 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.There is not a trend identified for the subclass of adverse event safety request for investigation for menstrual products, refer to the attached trend chart for may2016 - may2019.There is no further action required.Follow-up (29may2019): new information received from product quality complaints group included: investigation results.

• 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: 8568678
• MDR Text Key: 143851847
• Report Number: 1066015-2019-00126
• 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: 04/23/2019

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention