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

Lot Number S1666666N01/21

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Swelling (2091); Post Operative Wound Infection (2446); Fluid Discharge (2686); Partial thickness (Second Degree) Burn (2694)

Event Date 04/07/2018

Event Type  Injury  

Event Description

Had two blisters on her stomach/ burn and two blisters/noticed a pus, fluid like drainage coming from the area like when you pop a blister [burns second degree], she took the gauze off today ((b)(6) 2018) and noticed a pus [wound infection] , she put it on between 2 to 3 am/she fell asleep with it on and woke around 10 or 11 am/went to wipe it off/did not check skin under the product while wearing thermacare/the patient read the usage [intentional device misuse] , uses the products for endometriosis [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) caucasian (reported as other white) female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number s1666666n01/21 , expiration date dec2019, on (b)(6) 2018 at 1 wrap applied as directed for cramps/ cramp type pain and endometriosis.There were no medical history and no concomitant medications.The patient previously used thermacare heatwraps about once a month; and she did not experience any adverse event.The patient did not previously use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The patient used thermacare menstrual about 5 hours on (b)(6) 2018.She put it on between 2 to 3 am.She was watching a movie.She fell asleep with it on and woke around 10 or 11 am and thought she had sticky residue from the product and went to wipe it off and discovered two blisters on her stomach.She had used them before and had never been burned from them.She took the gauze off today ((b)(6) 2018) and noticed a pus, fluid like drainage coming from the area like when you pop a blister.They looked really gross.She applied it to her underwear garment and did not put on her skin.There was sticky on one side and medication on the other.She applied the sticky to her underwear and the other side on her belly.No lab data was provided.The patient was not currently under the care of a physician for any medical condition.The patient classified her skin tone as fair, did not have sensitive skin or any abnormal skin conditions.The patient did not engage in exercise while using the product (for example, running, bicycling).The patient read the usage instructions on thermacare before she used the product.She did not check her skin under the product while wearing thermacare.The patient was not taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced.The patient did not consult a healthcare professional for the symptoms.The action taken in response to the events for thermacare menstrual was permanently withdrawn on (b)(6) 2018.She had thrown the wrap away that burned her.Therapeutic measures were taken and included she applied neosporin and a burn relief product.She had not used a burn cream that her son had left over but was considering it.The outcome of event burn blister was not recovered.The outcome of other events was unknown.The patient considered there is a reasonable possibility that the event burn and two blisters was related to the device.Company clinical evaluation comment: based on the information provided, the events of burns second degree, wound infection and intentional device misuse are as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The reported event of device use issue is assessed as non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of burns second degree, wound infection and intentional device misuse are as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The reported event of device use issue is assessed as non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] had two blisters on her stomach/ burn and two blisters/noticed a pus, fluid like drainage coming from the area like when you pop a blister [burns second degree] , she took the gauze off today (09apr2018) and noticed a pus [wound infection] , she put it on between 2 to 3am/she fell asleep with it on and woke around 10 or 11 am/went to wipe it off/did not check skin under the product while wearing thermacare/the patient read the usage [intentional device misuse] , uses the products for endometriosis [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A 36-year-old caucasian (reported as other white) female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number s1666666n01/21, expiration date dec2019) on (b)(6) 2018 at 1 wrap applied as directed for cramps/ cramp type pain and endometriosis.There were no medical history and no concomitant medications.The patient previously used thermacare heatwraps about once a month; and she did not experience any adverse event.The patient did not previously use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The patient used thermacare menstrual about 5 hours on (b)(6) 2018.She put it on between 2 to 3am.She was watching a movie.She fell asleep with it on and woke around 10 or 11 am and thought she had sticky residue from the product and went to wipe it off and discovered two blisters on her stomach.She had used them before and had never been burned from them.She took the gauze off today (b)(6) 2018) and noticed a pus, fluid like drainage coming from the area like when you pop a blister.They looked really gross.She applied it to her underwear garment and did not put on her skin.There was sticky on one side and medication on the other.She applied the sticky to her underwear and the other side on her belly.No lab data was provided.The patient was not currently under the care of a physician for any medical condition.The patient classified her skin tone as fair, did not have sensitive skin or any abnormal skin conditions.The patient did not engage in exercise while using the product (for example, running, bicycling).The patient read the usage instructions on thermacare before she used the product.She did not check her skin under the product while wearing thermacare.The patient was not taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced.The patient did not consult a healthcare professional for the symptoms.The action taken in response to the events for thermacare menstrual was permanently withdrawn on (b)(6) 2018.She had thrown the wrap away that burned her.Therapeutic measures were taken and included she applied neosporin and a burn relief product.She had not used a burn cream that her son had left over but was considering it.The outcome of event burn blister was not recovered.The outcome of other events was unknown.The patient considered there is a reasonable possibility that the event burn and two blisters was related to the device.Follow-up (b)(6) 2018): new information received from a contactable physician includes: the physician denied being provided information regarding an adverse event with use of the product and could not confirm occurrence of the events reported by the patient.The physician declined further follow-up.Lot number was confirmed as invalid.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of burns second degree, wound infection and intentional device misuse are as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The reported event of device use issue is assessed as non-serious.The events are medically assessed as associated with the use of the device.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.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of burns second degree, wound infection and intentional device misuse are as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The reported event of device use issue is assessed as non-serious.The events are medically assessed as associated with the use of the device.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.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

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 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.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.Rsnbly suggest device malfunction?: no.Severity of harm: n/a.Site sample status: not received.

Event Description

Event verbatim [preferred term].Had two blisters on her stomach/ burn and two blisters/noticed a pus, fluid like drainage coming from the area like when you pop a blister [burns second degree], she took the gauze off today (b)(6) 2018 and noticed a pus [wound infection].She put it on between 2 to 3am/she fell asleep with it on and woke around 10 or 11 am/went to wipe it off/did not check skin under the product while wearing thermacare/the patient read the usage [intentional device misuse], uses the products for endometriosis [device use issue].Narrative: this is a spontaneous report from a contactable consumer reported for herself.A 36-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number reported as s1666666n01/21, but confirmed as invalid), expiration date dec2019.On (b)(6) 2018 at 1 wrap applied as directed for cramps/ cramp type pain and endometriosis.There were no medical history and no concomitant medications.The patient previously used thermacare heatwraps about once a month; and she did not experience any adverse event.The patient did not previously use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The patient used thermacare menstrual about 5 hours on (b)(6) 2018.She put it on between 2 to 3am.She was watching a movie.She fell asleep with it on and woke around 10 or 11 am and thought she had sticky residue from the product and went to wipe it off and discovered two blisters on her stomach.She had used them before and had never been burned from them.She took the gauze off today (b)(6) 2018 and noticed a pus, fluid like drainage coming from the area like when you pop a blister.They looked really gross.She applied it to her underwear garment and did not put on her skin.There was sticky on one side and medication on the other.She applied the sticky to her underwear and the other side on her belly.No lab data was provided.The patient was not currently under the care of a physician for any medical condition.The patient classified her skin tone as fair, did not have sensitive skin or any abnormal skin conditions.The patient did not engage in exercise while using the product (for example, running, bicycling).The patient read the usage instructions on thermacare before she used the product.She did not check her skin under the product while wearing thermacare.The patient was not taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced.The patient did not consult a healthcare professional for the symptoms.The action taken in response to the events for thermacare menstrual was permanently withdrawn on (b)(6) 2018.She had thrown the wrap away that burned her.Therapeutic measures were taken and included she applied neosporin and a burn relief product.She had not used a burn cream that her son had left over but was considering it.The outcome of event burn blister was not recovered.The outcome of other events was unknown.The patient considered there is a reasonable possibility that the event burn and two blisters was related to the device.Per the product complaint group: the caller reads paa: # from the product wrapper.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.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.Reasonably suggest device malfunction: no; severity of harm: n/a.Site sample status: not received.Follow-up (01may2018): new information received from a contactable physician includes: the physician denied being provided information regarding an adverse event with use of the product and could not confirm occurrence of the events reported by the patient.The physician declined further follow-up.Lot number was confirmed as invalid.Follow-up attempts are completed.No further information is expected.Follow-up (22jun2018): follow-up attempts completed.No further information expected.Follow-up (25jun2020): new information received from product quality complaint group 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: 7428537
• MDR Text Key: 105559002
• Report Number: 1066015-2018-00052
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2018

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
• Device Expiration Date: 12/01/2019
• Device Lot Number: S1666666N01/21
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/03/2018; 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 90