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

Lot Number L30381

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Sweating (2444); Partial thickness (Second Degree) Burn (2694)

Event Date 10/28/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] burn blister [burns second degree] , i have been active and sweated a bit [hyperhidrosis] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program selbstmedikation from a contactable consumer.A female patient started to receive thermacare heatwrap (thermacare menstrual), l30381, expiration date: 31dec2017, at unknown dose from unknown date for menstrual pain.Medical history included menstrual discomfort from time to time.The patient's concomitant medications were not reported.The patient reported that on the date of reporting, it happened for the second time, that she had had burn blisters from it on (b)(6) 2017.Additional information as reported by the consumer: "of course, i have been active and sweated a bit, which i do also when using the other thermacares and nothing like this has ever happened.I also do not worn particularly tight clothing." the action taken in response to the events for thermacare heatwrap was unknown.The outcome of burn blister was not resolved.The outcome of "sweated a bit" 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.

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 per menstrual, spec-22087, effective: 30-jun-2014.Complaint stems from "a heat wrap caused burn blisters".The cause of the "burn 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

Burn blister, approximately 0.5 cm big blister [burns second degree], heatwrap was attached to the body, read usage instructions prior to use [intentional device misuse], heatwrap was hotter than before [device issue], i have been active and sweated a bit [hyperhidrosis].Case narrative: this is a spontaneous report from a pfizer-sponsored program, selbstmedikation.A contactable consumer reported a (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare menstrual) (device lot number: l30381, expiration date: dec2017) from (b)(6) 2017 for menstrual pain.Medical history included menstrual discomfort from time to time.The patient's concomitant medication was reported as none.Past product history included thermacare heatwraps (thermacare heatwraps) (reported as different versions of the heatwrap) from an unspecified date (reported as "for several years") for an unspecified indication and experienced burn blisters on an unspecified date and thermacare heatwraps (thermacare lower back & hip) from an unspecified date for an unspecified indication and she used during sleep and there were no symptoms with the exception of sweaty and slightly reddened skin.On (b)(6) 2017, the patient reported she used the menstrual heatwrap for about 6 hours and experienced burn blisters from it.She stated the heatwrap was pleasantly warm, the skin slightly red but not unpleasant and she sweated a bit.After about 6 hours, the patient reported on the left side the heatwrap was hotter than before.She took a look under the heatwrap and discovered an approximately 0.5 cm big blister.The patient reported she was wearing a snug waistband and several layers of clothing over the heatwrap.She mentioned she does not wear particularly tight clothing.The patient stated the heatwrap was attached to the body.The heatwrap was adhered in the slip as described, jeans above, for an about 1 hour car drive.She checked her skin about 5 times while wearing thermacare.The patient reported the usage instructions were read prior to heatwrap use.The patient already often used this product (about 10 times) and experienced blisters only twice (there were no special circumstances, no special clothing was worn during the application, normal daily employment, car driving, moving, couch and so on).The patient assessed her skin tone as medium.She denied having sensitive skin or any abnormal skin conditions.The patient reported she used other heat products for pain relief regularly without incompatibilities.She did not engage in exercise while wearing the heatwrap.Action taken in response to the events for thermacare heatwrap was permanently withdrawn on 28oct2017.No therapeutic measures were taken as a result of the events.No healthcare professional was consulted.Clinical outcome of the event burn blister was resolving.Clinical outcome of the remaining events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.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 per menstrual, spec-22087, effective: 30-jun-2014.Complaint stems from "a heat wrap caused burn blisters".The cause of the "burn 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 (13nov2017): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (14nov2017): new information received from a contactable other hcp (patient was a pharmaceutical technician) includes: patient data, past product history, no concomitant medication, suspect product start/stop dates, reaction data (additional events of intentional device misuse and device issue), events outcomes, no therapeutic measures taken and no healthcare professional consulted.Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events burn blisters, intentional device misuse and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event sweaty is non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events burn blisters, intentional device misuse and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event sweaty is non-serious.The events are 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: 6992927
• MDR Text Key: 90759763
• Report Number: 1066015-2017-00153
• 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,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2017

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: 12/01/2017
• Device Lot Number: L30381
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2017
• 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
• Patient Age: 31 YR