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

Lot Number M61538

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Inflammation (1932); Pain (1994); Skin Discoloration (2074)

Event Date 09/21/2016

Event Type  Injury  

Event Description

Event verbatim [preferred term] serious blistering burn [burns second degree] , burned area turned reddish and black [skin discolouration] , inflamed [inflammation] ,.Case narrative:this is a spontaneous report based on the information received by pfizer from us fda (report #: mw5064755) from a contactable consumer.A patient of unspecified age ethnicity and gender started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number m61538.01/09, expiration date 31dec2018, from an unspecified date to an unspecified date at an unspecified indication for pain.The patient medical history was not reported.Concomitant medication included potassium citrate (potassium citrate), calcium citrate, cholecalciferol (citracal), cyanocobalamin (vit b 12), cholecalciferol (vit d3) and cpap machine.The patient reported "i used thermal care heat wraps for 6 hours on my abdomen to relieve the pain i was having.It resulted to a serious blistering burn.A day after the burned area turned reddish and black and inflamed until now.It's about 3 inches long and 3 inches wide" on an unspecified date with outcome of unknown.The action taken with thermacare heatwrap 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 events burn blister, skin discoloration, and inflammation as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device., comment: based on the information provided, the events burn blister, skin discoloration, and inflammation as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.

Event Description

3rd degree burn on abdomen.Serious blistering burn/still have blister wound-burn [burns second degree].Burned area turned reddish and black.Inflamed.Scarring.Was sleeping while wearing the product.[device use error].She read the usage instructions before using the product, wore the product while sleeping.[intentional device misuse].Case description: this is a spontaneous report based on the information received by pfizer from us fda (report #: mw5064755) from a contactable consumer.A (b)(6) female patient of unspecified ethnicity started to use thermacare heatwrap (thermacare menstrual), device lot number m61538.01/09 (also reported as m61538), expiration date 31dec2018, from an unspecified date to an unspecified date at an unspecified indication for abdominal cramps.The patient medical history included sensitive skin.Concomitant medication included potassium citrate (potassium citrate) since 2014, calcium citrate, cholecalciferol (citracal) since 2014, cyanocobalamin (vit b 12) since 2014, cholecalciferol (vit d3) as needed since 2014 and cpap machine.Past product history included thermacare in (b)(6) 2016 for 6 hours and had no adverse effect.The patient experienced a serious blistering burn on (b)(6) 2016.The burned area turned reddish and black and inflamed.She also described it as 3rd degree burn on her abdomen.It's about 3 inches long and 3 inches wide" on (b)(6) 2016 with outcome of not resolved (still had blister wound-burn, however it was getting smaller but showed scarring).She reported she was hospitalized due to the events.The action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2016.Treatment for the event included neosporin and clobetasol.The patient was not pregnant.She classified her skin tone as medium and reported she has sensitive skin.She reported she does not have any abnormal skin conditions.She reported she used the heatwrap for 4 hours for one day.The patient had previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) in (b)(6) 2016 with no adverse effect.The patient reported she was sleeping while wearing the product and attached the adhesive to "body clothing".She did not engage in exercise while using the product, she did check under the product while wearing when she felt pain on her skin.She read the usage instructions before using the product.Additional information has been requested and will be provided as it becomes available.Follow-up (14nov2016): new information received from a contactable consumer included patient data (age and gender), relevant medical history, concomitant medication data (start dates), past product use, product data (the product was updated from thermacare heatwraps multi-purpose muscle pain to thermacare menstrual, additional lot #, indication, action taken) and reaction data (additional events of 3rd degree burn on her abdomen, scarring, and read the instructions before using and wore the product while sleeping, outcome, additional seriousness criteria of hospitalization and treatment).Company clinical evaluation comment based on the information provided, the events burn third degree , burn blister, skin discoloration, inflammation, scarring, device use error, and intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

A 3rd degree burn on abdomen , serious blistering burn/still have blister wound-burn [burns second degree] , burned area turned reddish and black [skin discolouration] , inflamed [inflammation] , scarring [scar] , was sleeping while wearing the product [device use error] , she read the usage instructions before using the product, wore the product while sleeping [intentional device misuse] ,.Case narrative:this is a spontaneous report based on the information received by pfizer from us fda (report #: mw5064755) from a contactable consumer.A (b)(6) female patient of unspecified ethnicity started to use thermacare heatwrap (thermacare menstrual) (device lot number: m61538, expiration date: dec2018) from an unspecified date for abdominal cramps.The patient's medical history included sensitive skin.Concomitant medication included potassium citrate (potassium citrate) since 2014, calcium citrate, cholecalciferol (citracal) since 2014, cyanocobalamin (vit b 12) since 2014, cholecalciferol (vit d3) as needed since 2014 and cpap machine.Past product history included thermacare in (b)(6) 2016 for 6 hours and had no adverse effect.The patient experienced a serious blistering burn on (b)(6) 2016.The burned area turned reddish and black and inflamed.She also described it as a 3rd degree burn, 3 inches long and 3 inches wide, on her abdomen with outcome of not resolved (still had blister wound-burn, however it was getting smaller but showed scarring).She reported she was hospitalized due to the events.The patient was not pregnant.She classified her skin tone as medium.The patient reported she does not have any abnormal skin conditions.She had previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) in (b)(6) 2016 with no adverse effect.The patient reported she was sleeping while wearing the product and attached the adhesive to "body clothing".She did not engage in exercise while using the product.The patient did check under the product while wearing the heatwrap when she felt pain on her skin.She read the usage instructions before using the product.Action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included neosporin and clobetasol.Clinical outcome of the event skin discoloration was resolved on an unspecified date.Clinical outcome of the remaining events was not resolved.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (14nov2016): new information received from a contactable consumer included patient data (age and gender), relevant medical history, concomitant medication data (start dates), past product use, product data (the product was updated from thermacare heatwraps multi-purpose muscle pain to thermacare menstrual, indication, action taken) and reaction data (additional events of 3rd degree burn on her abdomen, scarring, and read the instructions before using and wore the product while sleeping, outcome, additional seriousness criteria of hospitalization and treatment).Follow-up (30nov2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Company clinical evaluation comment: based on the information provided, the events burn third degree, burn blister, skin discoloration, inflammation, scarring, device use error, and intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device., comment: based on the information provided, the events burn third degree, burn blister, skin discoloration, inflammation, scarring, device use error, and intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, 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 (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 5999958
• MDR Text Key: 56478014
• Report Number: 1066015-2016-00127
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2016

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: 12/01/2018
• Device Lot Number: M61538
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/22/2016; 12/07/2016
• 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
• Treatment: CITRACAL; POTASSIUM CITRATE; VIT B 12; VIT D3
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR