MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Lot Number L72536S; L72536

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/01/2015

Event Type  Injury  

Event Description

Skin burn - since 14 days she had blisters [burns second degree].Case description: this is a spontaneous report from a contactable pharmacist via medical information team.An elderly female patient (reported as over 70-years-old) of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: l72536s, expiration date: feb2018) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On an unspecified date in nov2015, the patient reported she applied the heatwrap directly to the skin and developed skin burn.She reported since 14 days she had blisters.Action taken with the suspect product 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 blister as described in this case is 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.Case comment: based on the information provided, the event of burn blister as described in this case is 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

Blisters on the skin (neck area) since about 2-3 weeks [burns second degree].Case description: this is a spontaneous report from a contactable pharmacist via medical information team.A (b)(6) female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: l72536s, expiration date: feb2018) from nov2015 for the first time transdermal once for 8 hours for an unspecified indication.The patient's medical history was not reported.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.About 2-3 weeks prior to the initial report in (b)(6) 2015, the patient applied the heatwrap directly to the skin and developed skin burn.She reported since 14 days she had blisters.In the neck area burn blisters developed for the first time on the warm sites.The administration was on naked skin (despite the recommendation of the pharmacy not to administer on naked skin).The burn blisters were treated for 14 days with an ointment and had resolved completely with no expectation of lasting damage in 2015.An operation was not necessary.A causal relationship to thermacare was suspected due to the heat.Action taken with the suspect product was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (21dec2015): new reported from contactable pharmacist includes: patient age, no concomitant medication, product start date, event treatment, event outcome.Causality assessment.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the event of burn blister as described in this case is 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 event of burn blister as described in this case is 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, there was one cold wrap, investigations were completed (b)(4); root cause was determined to be equipment.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

Case description: this is a spontaneous report from a contactable pharmacist via medical information team.A (b)(6) female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: l72536s and l72536, expiration date: feb2018) from (b)(6) 2015 for the first time transdermal once for 8 hours for an unspecified indication.The patient's medical history was not reported.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.About 2-3 weeks prior to the initial report in (b)(6) 2015, the patient applied the heatwrap directly to the skin and developed skin burn.She reported since 14 days she had blisters.In the neck area burn blisters developed for the first time on the warm sites.The administration was on naked skin (despite the recommendation of the pharmacy not to administer on naked skin).The burn blisters were treated for 14 days with an ointment and had resolved completely with no expectation of lasting damage in 2015.An operation was not necessary.A causal relationship to thermacare was suspected due to the heat.Action taken with the suspect product was unknown.New information received from product quality on 14dec2015, investigation summary for lot # l72536 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, there was one cold wrap, investigations were completed (b)(4) and (b)(4); root cause was determined to be equipment.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 (21dec2015): new reported from contactable pharmacist includes: patient age, no concomitant medication, product start date, event treatment, event outcome.Causality assessment.Follow-up attempts completed.No further information expected.Follow-up (14dec2015): new information received from product quality included: investigation results for lot # l72536.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the event of burn blister as described in this case is 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 eu and 30-day fda reportability.Case comment: based on the information provided, the event of burn blister as described in this case is 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 eu 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, there was one cold wrap, investigations were completed (b)(4); root cause was determined to be equipment.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

Case description: this is a spontaneous report from a contactable pharmacist via medical information team.A (b)(6) female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: l72536s and l72536, expiration date: feb2018) from (b)(6) 2015 for the first time transdermal once for 8 hours for an unspecified indication.The patient's medical history was not reported.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.About 2-3 weeks prior to the initial report in (b)(6) 2015, the patient applied the heatwrap directly to the skin and developed skin burn.She reported since 14 days she had blisters.In the neck area burn blisters developed for the first time on the warm sites.The administration was on naked skin (despite the recommendation of the pharmacy not to administer on naked skin).The burn blisters were treated for 14 days with an ointment and had resolved completely with no expectation of lasting damage in 2015.An operation was not necessary.A causal relationship to thermacare was suspected due to the heat.Action taken with the suspect product was unknown.New information received from product quality on 14dec2015, investigation summary for lot # l72536 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, there was one cold wrap, investigations were completed (b)(4); root cause was determined to be equipment.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 (21dec2015): new reported from contactable pharmacist includes: patient age, no concomitant medication, product start date, event treatment, event outcome.Causality assessment.Follow-up (14dec2015): new information received from product quality included: investigation results for lot # l72536.Follow-up (24feb2016): new information received from the drug commission of the (b)(6) pharmacist (b)(6) includes: report number (b)(4).Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the event of burn blister as described in this case is 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 eu and 30-day fda reportability.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• 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: 5307617
• MDR Text Key: 33825256
• Report Number: 1066015-2015-00152
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/30/2015

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: 02/01/2018
• Device Lot Number: L72536S; L72536
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2016; 01/13/2016; 03/04/2016
• 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: 70