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

Device Problem Overheating of Device (1437)

Patient Problems Erythema (1840); Itching Sensation (1943); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

The skin in the area of the wrap was red and itchy and peeled off in places.[erythema] , the skin in the area of the wrap was red and itchy and peeled off in places [pruritus] , the skin in the area of the wrap was red and itchy and peeled off in places [skin exfoliation] , i feel this one i had got hotter than normal [device issue], case narrative: the initial case was missing the following minimum criteria: other - info not qualifying for ae reporting-cep.Upon receipt of follow-up information on 01oct2018, this case now contains all required information to be considered valid.This is a spontaneous report from a pfizer-sponsored program pfizer thermacare.Com testimonials.A contactable consumer reported a (b)(6) female patient started to receive thermacare heatwrap (thermacare menstrual) from an unspecified date for painful cramps.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported she was recently disappointed after using a heatwrap during the day while at work.She stated she had a desk job and never had an issue wearing the heatwrap during her time of the month.When she went to take off the heatwrap later that day, the skin in the area of the wrap was red and itchy and peeled off in places.She stated she did not wear them to bed and only wore them once a month for a day or two, not consecutively.The patient mentioned she felt this heatwrap had gotten hotter than normal towards the end of the day for some reason.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Amendment: this follow-up report is being submitted to amend previously reported information: updated event 'feeling hot' to 'device issue'.Follow-up (08may2019): follow-up attempts are completed.No further information is expected.Follow-up (01oct2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the available information, the events skin in the "area of the wrap was red and itchy and peeled off in places, and felt heatwrap had gotten hotter than normal" as described are considered serious bodily injury, potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the suspect device and the events cannot be ruled out., comment: based on the available information, the events skin in the "area of the wrap was red and itchy and peeled off in places, and felt heatwrap had gotten hotter than normal" as described are considered serious bodily injury, potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the suspect device and the events cannot be ruled out.

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 product quality related trend identified for the subclass wrap/patch/pad too hot.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 wrap/patch/pad too hot.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

The skin in the area of the wrap was red and itchy and peeled off in places.[erythema] , the skin in the area of the wrap was red and itchy and peeled off in places [pruritus] , the skin in the area of the wrap was red and itchy and peeled off in places [skin exfoliation] , i feel this one i had got hotter than normal [device issue].Case narrative: the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on 01oct2018, this case now contains all required information to be considered valid.This is a spontaneous report from a pfizer-sponsored program pfizer thermacare.Com testimonials.A contactable consumer reported a 32-year-old female patient started to receive thermacare heatwrap (thermacare menstrual) from an unspecified date for painful cramps.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported she was recently disappointed after using a heatwrap during the day while at work.She stated she had a desk job and never had an issue wearing the heatwrap during her time of the month.When she went to take off the heatwrap later that day, the skin in the area of the wrap was red and itchy and peeled off in places.She stated she did not wear them to bed and only wore them once a month for a day or two, not consecutively.The patient mentioned she felt this heatwrap had gotten hotter than normal towards the end of the day for some reason.The action taken with the suspect product and the outcome of the events was unknown.Per the product quality group: 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 product quality related trend identified for the subclass wrap/patch/pad too hot.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 wrap/patch/pad too hot.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 return sample has not been received at the site for evaluation as of 18nov2019.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: updated event 'feeling hot' to 'device issue'.Follow-up (08may2019): follow-up attempts are completed.No further information is expected.Follow-up (01oct2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (19nov2019): new information received from a product complaint group includes investigation results.Company clinical evaluation comment based on the available information, the events skin in the "area of the wrap was red and itchy and peeled off in places, and felt heatwrap had gotten hotter than normal" as described are considered serious bodily injury, potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.A causal relationship between the suspect device and the events 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 remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the available information, the events skin in the "area of the wrap was red and itchy and peeled off in places, and felt heatwrap had gotten hotter than normal" as described are considered serious bodily injury, potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.A causal relationship between the suspect device and the events 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 remedial action/corrective action/field safety corrective action is suggested at this time.

• 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: 9257934
• MDR Text Key: 181963616
• Report Number: 1066015-2019-00255
• 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: 02/05/2018

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR