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

Lot Number T48927

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Nerve Damage (1979); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 03/04/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term]: 2nd degree plus burns/felt something leaking/the skin has blistered and broken/some nerve damage in the burn area/she has lost all sensation in the area/still feel the itching [burns second degree], 1 heatwrap applied to her abdomen for lower abdominal pain from ovarian cysts [device use issue].Case narrative: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) caucasian female patient (non-pregnant) started to receive thermacare heatwrap (thermacare lower back & hip), (b)(4), device lot number t48927, expiration date oct2020, from (b)(6) 2018 at 1 heatwrap applied to her abdomen for lower abdominal pain from ovarian cysts.Medical history included ongoing fibromyalgia; neuropathy occasionally, it was tingling in her hands every now and then; disability.The patient's concomitant medications were not reported.The patient had neuropathy as a result of the topamax she took and she was told that it was a side effect that it would go away.She had been using these heatwraps off and on for many years and never had a problem.She reported that she had been using the product for close to 10 years and this was the first time she had a problem.The patient used one yesterday (on (b)(6) 2018) because she had been having lower abdominal pain.She said that she just took the lower back and hip heatwrap and flipped it around.She said that she received 2 degree plus burns on (b)(6) 2018.There was nothing to indicate there was problem when she had it on and it was not overly hot.She said that she did not realize there was a problem until she felt something leaking on the front of her pajamas.She said that she went to the urgent care and was treated there.She said that the urgent care did an examination and bandaged the area.The patient said that the burned areas had since blistered.She said that there were several areas where the skin has blistered and broken.The patient said that one of the issues was that there seemed to be some nerve damage in the burn area.She was told that this type of burn can burn the nerve endings and they told her that hopefully it would come back.She had lost all sensation in the area.The patient stated that she could still feel the itching and the burning from the burns, but not the surrounding skin.The patient said that she was seen in a er for the abdominal pain, they did testing then, but that was prior to her using the thermacare and was unrelated to her burns.The patient underwent lab tests and procedures which included dermatologic examination: burns on (b)(6) 2018.The patient had significant medical issues and was currently under the care of a physician.She said that it was nothing that had any impact on this other than the wrap.She classified her skin tone as fair.She did not have sensitive skin or any abnormal skin conditions.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date in (b)(6) 2018.The outcome of event burns second degree was not recovered.The outcome of the other 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 burns second degree as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device use issue is considered as non-serious.Both events are medically assessed as associated with the use of the device., comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device use issue is considered as non-serious.Both events are medically assessed as associated with the use of the device.

Manufacturer Narrative

Investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports she "received 2 degree plus burns" from wrap.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The returned sample did not show any obvious defects to the wrap.The product effect may vary with each individual.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.The product quality for the batch is not impacted by this complaint.Investigation summary: the root cause category is non-assignable (complaint not confirmed).Evaluation of the returned sample shows no obvious defects to the wrap.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 batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term]: 2nd degree plus burns, felt something leaking, quarter sized blister that had burst and skin sloughed off, some nerve damage in the burn area, lost all sensation in the area, still feel the itching [burns second degree] , 1 heatwrap applied to her abdomen for lower abdominal pain from ovarian cysts/on my abdomen/hip for ovarian cyst pain [device use issue].Case narrative: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) caucasian female patient (non-pregnant) started to use thermacare heatwrap (thermacare lower back & hip) ((b)(4), device lot number t48927, expiration date 31oct2020) from (b)(6) 2018 at 1 heatwrap applied to her abdomen for lower abdominal pain from ovarian cysts/ used on her abdomen/hip for ovarian cyst pain.Medical history included ongoing fibromyalgia; neuropathy occasionally, it was tingling in her hands every now and then; disability.The patient's concomitant medications were not reported.The patient had neuropathy as a result of the topamax she took and she was told that it was a side effect that it would go away.She had been using these heatwraps off and on for many years and never had a problem.She reported that she had been using the product for close to 10 years and this was the first time she had a problem.The patient used one yesterday (on (b)(6) 2018) because she had been having lower abdominal pain.She said that she just used the lower back and hip heatwrap and flipped it around.The patient used thermacare lower back & hip on her abdomen/hip for ovarian cyst pain.She had it on during the day and removed it when it felt cool (7-8 hours).She said that she received 2 degree plus burns on (b)(6) 2018.There was nothing to indicate there was problem when she had it on and it was not overly hot.She said that she did not realize there was a problem until she felt something leaking on the front of her pajamas.After removal, the patient felt dampness on her clothing and itching/burning skin.The dampness was the result of a quarter sized blister that had burst and the skin sloughed off.After checking mirror, the patient realized she had (7) raised red burns and several were blistering and oozing.She said that she went directly to the urgent care where burns were diagnosed.The patient said that the burned areas had since blistered.She said that there were several areas where the skin has blistered and broken.The patient said that one of the issues was that there seemed to be some nerve damage in the burn area.She was told that this type of burn can burn the nerve endings and they told her that hopefully it would come back.She had lost all sensation in the area.The patient stated that she could still feel the itching and the burning from the burns, but not the surrounding skin.And she was told the numbness across her abdomen was due to nerve damage that would probably clear up in time.The patient had been treating the burns daily and changing bandages.Some have improved, others have not.There was still a large open wound on her stomach.The patient said that she was seen in a er for the abdominal pain, they did testing then, but that was prior to her using the thermacare and was unrelated to her burns.The patient underwent lab tests and procedures which included dermatologic examination: burns on (b)(6) 2018.The patient had significant medical issues and was currently under the care of a physician.She said that it was nothing that had any impact on this other than the wrap.She classified her skin tone as fair.She did not have sensitive skin or any abnormal skin conditions.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date in (b)(6) 2018.The outcome of event burns second degree was recovering.The outcome of the other events was unknown.The device was available for evaluation.According to investigation results from product quality complaints: investigation summary as of 05apr2018: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports she "received 2 degree plus burns" from wrap.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The returned sample did not show any obvious defects to the wrap.The product effect may vary with each individual.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.The product quality for the batch is not impacted by this complaint.Investigation summary as of 06apr2018: the root cause category is non-assignable (complaint not confirmed).Evaluation of the returned sample shows no obvious defects to the wrap.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 batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Us fda assessed the case as serious due to important medical event.Additional information has been requested and will be provided as it becomes available.Follow-up (05apr2018 and 06apr2018): new information received from product quality complaints included: investigation results.Additional information received from a contactable consumer via us fda (regulatory authority report number: mw5075767) included: suspect product details (including expiration date and indication), further event details and event outcome.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device use issue is considered as non-serious.Both events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device use issue is considered as non-serious.Both events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

• Brand Name: THERMACARE LOWER BACK & HIP
• 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: 7331102
• MDR Text Key: 102148587
• Report Number: 1066015-2018-00034
• 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
• Report Date: 03/05/2018

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: 10/31/2020
• Device Lot Number: T48927
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 44 YR
• Patient Weight: 74