MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE FUER FLEXIBLE ANWENDUNG; DISPOSABLE PACK, HOT

Lot Number M63623

Device Problem Unexpected Therapeutic Results (1631)

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

Event Date 03/15/2016

Event Type  Injury  

Event Description

Two burn blisters on her upper back/shoulder girdle [burns second degree].Case description: this is a spontaneous report from the pfizer-sponsored program brand websites for division consumer healthcare (b)(6).A contactable female consumer reported a female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare fuer flexible anwendung), from an unspecified date for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient previously used hermacare products regularly and no problem.On (b)(6) 2016, the patient she used thermacare heatwrap, it was comfortably warm - as usual - but as she removed it in the evening she noticed two burn blisters.This happened for the first time and scared her, especially as she had not noticed it before during application of the heatwrap.The consumer forwarded a photo displaying that the burn blisters are on her upper back/shoulder girdle and she asked for recommendations how to prevent this in the future.The 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 "burn blister" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is 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 "burn blister" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets initial 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.

Event Description

Case description: this is a spontaneous report from the pfizer-sponsored program, brand websites for division consumer healthcare (b)(6).A contactable consumer reported a (b)(6)-year-old female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare fuer flexible anwendung) (suspect lot #: m63623, expiration date: aug2018) from (b)(6) 2016 at approximately 7:00 am for "prevention, because i am often outside in the cold".The patient's medical history was not reported.Concomitant medications were reported as none.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no problem.On (b)(6) 2016, the patient reported she used thermacare heatwrap directly on her body (not over clothing) and it was comfortably warm, as usual.For a short time, the patient indicated the heatwrap was a bit warmer, but not hot.She stated as she removed it in the evening, after wearing the heatwrap for approximately 10 to 12 hours, she noticed 2 burn blisters.This happened for the first time and scared her, especially as she had not noticed it before during application of the heatwrap.She mentioned she did not check the skin under the wrap during heatwrap use.The patient forwarded a photo displaying the burn blisters on her upper back/shoulder girdle.She reported her duration of use of the heatwraps per day was 3 to 10 hours.The patient assessed her skin tone as very light.She denied having any skin disorders.The patient denied being pregnant or in menopause.She stated she used other heating devices for pain previously without experiencing any problems.The patient read the usage instructions prior to using the heatwrap.She did not perform any sports during use of the heatwrap.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016 at approximately 8:00 pm.Clinical outcome of the event was resolving.According to the product quality complaint group: 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.Additional information has been requested and will be provided as it becomes available.Follow-up (30mar2016): new information received from the same contactable consumer includes: patient details, no concomitant medications, suspect product indication, suspect product start/stop date, suspect product lot number and expiration date, action taken with suspect product, reaction data (additional event of device misuse) and event outcome.Follow-up (07apr2016): new information received from product quality complaint group includes investigation results.Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the event "burn blister after wearing the heatwrap for approximately 10 to 12 hours" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets final (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the event "burn blister after wearing the heatwrap for approximately 10 to 12 hours" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets final (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.

Event Description

Two (2) burn blisters on her upper back/shoulder girdle [burns second degree].Used heatwrap for 10 to 12 hours, did not check skin under heatwrap during use [intentional device misuse].Case description: this is a spontaneous report from the pfizer-sponsored program, brand websites for devision consumer healthcare (b)(4).A contactable consumer reported a (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare fuer flexible anwendung) (suspect lot #: m63623, expiration date: aug2018) from (b)(6) 2016 at approximately 7:00 am for "prevention, because i am often outside in the cold".The patient's medical history was not reported.Concomitant medications were reported as none.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no problem.On (b)(6) 2016, the patient reported she used thermacare heatwrap directly on her body (not over clothing) and it was comfortably warm, as usual.For a short time, the patient indicated the heatwrap was a bit warmer, but not hot.She stated as she removed it in the evening, after wearing the heatwrap for approximately 10 to 12 hours, she noticed 2 burn blisters.This happened for the first time and scared her, especially as she had not noticed it before during application of the heatwrap.She mentioned she did not check the skin under the wrap during heatwrap use.The patient forwarded a photo displaying the burn blisters on her upper back/shoulder girdle.She reported her duration of use of the heatwraps per day was 3 to 10 hours.The patient assessed her skin tone as very light.She denied having any skin disorders.The patient denied being pregnant or in menopause.She stated she used other heating devices for pain previously without experiencing any problems.The patient read the usage instructions prior to using the heatwrap.She did not perform any sports during use of the heatwrap.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016 at approximately 8:00 pm.Clinical outcome of the event was resolving.Additional information has been requested and will be provided as it becomes available.Follow-up (30mar2016): new information received from the same contactable consumer includes: patient details, no concomitant medications, suspect product indication, suspect product start/stop date, suspect product lot number and expiration date, action taken with suspect product, reaction data (additional event of device misuse) and event outcome.Company clinical evaluation comment based on the information provided, the event "burn blister after wearing the heatwrap for approximately 10 to 12 hours" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is 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 "burn blister after wearing the heatwrap for approximately 10 to 12 hours" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets follow-up 10-day eu and 30-day fda reportability.

• Brand Name: THERMACARE FUER FLEXIBLE ANWENDUNG
• 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: 5516978
• MDR Text Key: 40944512
• Report Number: 1066015-2016-00052
• 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: consumer,foreign
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2016

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: 08/01/2018
• Device Lot Number: M63623
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 03/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/07/2016; 04/26/2016
• 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: 33 YR
• Patient Weight: 60