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

Lot Number L75963

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn, Thermal (2530)

Event Date 11/19/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] burns (with blisters according to the attached pictures) [burns second degree].Case narrative: this is a spontaneous report from a pfizer-sponsored program, brand websites for division consumer healthcare (b)(6).A contactable consumer reported a female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare menstrual) (device lot number l75963, expiration date mar2018) from (b)(6) 2017 to an unspecified date for menstrual pain.The patient's medical history and concomitant medications were not reported.The patient reported "i regularly use your heatwraps for menstrual pain.Yesterday ((b)(6) 2017), i last used one.Unfortunately, i noticed burns on the evening when i removed the wrap.It is the first time this has happened to me." the patient provided photos revealing blisters at the burn site.Action taken in response to the event for thermacare heatwrap was unknown.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 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 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.

Event Description

Event verbatim [preferred term] burns (with blisters according to the attached pictures) at lower abdomen [burns second degree] ,.Case narrative: this is a spontaneous report from a pfizer-sponsored program, brand websites for division consumer healthcare germany.A contactable consumer reported a female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare menstrual) (device lot number l75963, expiration date mar2018) from (b)(6) 2017 to an unspecified date for menstrual pain.The patient's medical history and concomitant medications were not reported.The patient reported "i regularly use your heatwraps for menstrual pain.Yesterday ((b)(6) 2017), i last used one.Unfortunately, i noticed burns on the evening when i removed the wrap.It is the first time this has happened to me." the patient provided photos revealing blisters at the burn site.The burn was located at lower abdomen.Action taken in response to the event for thermacare heatwrap was unknown.Clinical outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (23nov2017): new information received from the contactable consumer included: event details.Company clinical evaluation comment based on the information provided, the event of "burn 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 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

The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Complaint stems for consumer reporting "heat wrap caused burned blisters on the skin".The cause of the "burned blisters" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term] burns (with blisters according to the pictures) at lower abdomen [burns second degree].Case narrative:this is a spontaneous report from a pfizer-sponsored program, brand websites for division consumer healthcare germany.A contactable consumer reported a female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare menstrual) (device lot number l75963, expiration date mar2018) from (b)(6) 2017 to an unspecified date for menstrual pain.The patient's medical history and concomitant medications were not reported.The patient reported "i regularly use your heatwraps for menstrual pain.Yesterday ((b)(6) 2017), i last used one.Unfortunately, i noticed burns on the evening when i removed the wrap.It is the first time this has happened to me." the patient provided photos revealing blisters at the burn site.The burn was located at lower abdomen.Action taken in response to the event for thermacare heatwrap was unknown.Clinical outcome of the event was unknown.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Complaint stems for consumer reporting "heat wrap caused burned blisters on the skin".The cause of the "burned blisters" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.Additional information has been requested and will be provided as it becomes available.Follow-up (23nov2017): new information received from the contactable consumer included: event details.Follow-up (06dec2017): new information received from product quality complaint group includes investigation results.Company clinical evaluation comment: based on the information provided, the event of "burn 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 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
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 7054075
• MDR Text Key: 92837478
• Report Number: 1066015-2017-00165
• 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,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2017

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: 03/01/2018
• Device Lot Number: L75963
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/27/2017; 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention