MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number J632;LJ60032 06/25

Device Problem Insufficient Information (3190)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 11/27/2015

Event Type  Injury  

Event Description

Got burns and she had blisters on her back / at her waist [thermal burn].Got burns and she had blisters on her back / had burn and blister at her waist [blister].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back and hip), device lot number j632, expiration date may2017, via an unspecified route of administration from an unspecified date for an unspecified indication.Medical history included her feet were all dead and the product gives her lot of relief.Concomitant medication included metoprolol at 50mg for blood pressure.The patient used the product on ((b)(6) 2015), got burns and had blisters on her back/at her waist in (b)(6) 2015.The patient she just had blood work and everything was fine.The patient used bacitracin ointment on burns and blister.The outcome of the events 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 thermal burn and blister as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Got burns and she had blisters on her back by her waist, it was absorbed red [thermal burn] got burns and she had blisters on her back by her waist [blister] case description: this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number j632, expiration date may2017, via an unspecified route of administration from an unspecified date as she was on her feet all day.Medical history included her feet were all dead and the product gives her lot of relief.Concomitant medication included metoprolol at 50mg for blood pressure.The patient used the product on ((b)(6) 2015), and stated that she usually wears it all the time when it was a holiday and she got burns and she had blisters on her back by her waist and it was all over a t-shirt may be her t-shirt was not heavy enough she never had this reaction before, although she had worn a t-shirt, may be the t-shirt was too thin, when she took it off it was absorbed red and inside it was a blister on (b)(6) 2015.The patient she just had blood work and everything was fine.The patient used bacitracin ointment on burns and blister.The patient was recovered completely from the events.Additional information has been requested and will be provided as it becomes available.Follow-up (07dec2015): new information reported from a contactable consumer included: product indication, event description, onset date and outcome.Company clinical evaluation comment based on the information provided, the events thermal burn and blister as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets follow up 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn and blister as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets follow up 10-day eu and 30-day fda reportability.

Event Description

Case description: this is a spontaneous report from a contactable consumer.A (b)(6)+ caucasian female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number: j632 and lj60032 06/25, expiration date may2017, via an unspecified route of administration from an unspecified date for lower back pain as she was on her feet all day.Medical history included her feet were all dead and the product gives her a lot of relief.Concomitant medications included metoprolol at 50mg since 2014 for blood pressure.The patient used the product on (b)(6) 2015, and stated that she usually wears it all the time when it was a holiday and she got burns and she had blisters on her back by her waist and it was all over a t-shirt; maybe her t-shirt was not heavy enough; she never had this reaction before, although she had worn a t-shirt, may be the t-shirt was too thin, when she took it off after wearing thermacare 8 hours, it was absorbed red and inside it was a blister on (b)(6) 2015.The patient classified the skin tone is medium (neither light nor dark), she does not have sensitive skin, she does not have abnormal skin conditions.She previously used thermacare in 2014 for 3 days and did not experience the same problem.The patient did not check skin under the product while wearing thermacare, did not engage in exercise while using the product and she read the usage instructions on thermacare before she used the product.The patient said she just had blood work and everything was fine.The patient used bacitracin plus ointment on burns and blister.The patient was recovered completely from the events.Additional information has been requested and will be provided as it becomes available.Follow-up (07 dec 2015): new information reported from a contactable consumer included: product indication, event description, onset date and outcome.Follow up (22 dec 2015): new information reported from a contactable consumer in response to the non-hcp letter sent in that included: product indication and lot number, new event (did not check skin under the product while wearing thermacare).Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the events thermal burn, blister, and intentional product misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets follow up 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn, blister, and intentional product misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets follow up 10-day eu and 30-day fda reportability.

Manufacturer Narrative

The plant has reviewed this batch from a manufacturing and technical 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.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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.

Event Description

Case description: this is a spontaneous report from a contactable consumer.A (b)(6)-years-old caucasian female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number: j632 and lj60032 (b)(6), expiration date may2017, via an unspecified route of administration from an unspecified date for lower back pain as she was on her feet all day.Medical history included her feet were all dead and the product gives her lot of relief.Concomitant medication included metoprolol at 50mg since 2014 for blood pressure.The patient used the product on (b)(6) 2015, and stated that she usually wears it all the time when it was a holiday and she got burns and she had blisters on her back by her waist and it was all over a t-shirt may be her t-shirt was not heavy enough she never had this reaction before, although she had worn a t-shirt, may be the t-shirt was too thin, when she took it off after wearing thermacare 8 hours, it was absorbed red and inside it was a blister on (b)(6) 2015.The patient classified the skin tone is medium (neither light nor dark), she does not have sensitive skin, she does not abnormal skin conditions.She previously used thermacare in 2014 for 3 days and did not experienced same problem.The patient did not check skin under the product while wearing thermacare, did not engage in exercise while using the product and she read the usage instructions on thermacare before used the product.The patient she just had blood work and everything was fine.The patient used bacitracin plus ointment on burns and blister.The patient was recovered completely from the events.Upon follow-up reported on 10feb2016 from product complaint group, investigation summary included: the plant has reviewed this batch from a manufacturing and technical 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.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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.Additional information has been requested and will be provided as it becomes available.Follow-up (07dec2015): new information reported from a contactable consumer included: product indication, event description, onset date and outcome.Follow up (22dec2015): new information reported from a contactable consumer in response to the non-hcp letter sent in that included: product indication and lot number, new event (did not check skin under the product while wearing thermacare).Follow-up attempts completed.No further information expected.Follow-up (10feb2016): new information reported from a product complaint group included: investigation summary.Follow up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events thermal burn, blister, and intentional product misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets final 10-day (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn, blister, and intentional product misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets final 10-day (b)(6) and 30-day fda reportability.Evaluation summary: the plant has reviewed this batch from a manufacturing and technical 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.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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017 ; 2127334552
• MDR Report Key: 5306770
• MDR Text Key: 33800874
• Report Number: 1066015-2015-00153
• 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: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/07/2015

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: 05/01/2017
• Device Lot Number: J632;LJ60032 06/25
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/21/2015; 01/15/2016; 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 77