MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT

Lot Number T65617

Device Problem Overheating of Device (1437)

Patient Problems Pain (1994); Swelling (2091); Rupture (2208); Partial thickness (Second Degree) Burn (2694)

Event Date 05/11/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] blister/burned [burns second degree], blister is still open [blister rupture], get hotter and hotter and then finally, it was so hot [device issue], still having a lot of pain [device ineffective].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain, device lot number t65617, expiration date sep2020), via an unspecified route of administration on (b)(6) 2018 for pulled muscle in upper thigh.There are no concomitant products, medical conditions or test results to report at this time.The patient has used thermacare in the past and has not experienced problem/symptom during previous use.The patient recently purchased a 3 pack of smaller wraps to use for a pulled muscle in her upper thigh.The one was super-hot, and the others were not.At first, she applied the heatwrap to her body.When it started to get hot, she put cloth between her skin and the actual heat wrap so that it wouldn't get super-hot and it still remained to get hotter and hotter and then finally, it was so hot that she took it off and that is when she saw the blister to left upper thigh.The heatwrap burned her and she literally got a huge blister on (b)(6) 2018.The patient had used the heatwrap between 6-8 hours, put on in the morning and took off in the afternoon.The patient states the blister has broken, is still open and hasn't healed.She is still having a lot of pain from the pulled muscle in her upper thigh, but will not put a heatwrap on it now.She cleaned off the blister with hydrogen peroxide, put antibiotic cream on it and has the blister covered to make sure there was no infection.The patient stated she used another heatwrap far below the area of blister because of the cramping/her muscle problem, so it wouldn't affect the blister in any way.She found the next two heatwraps were hardly even hot.Patient classified skin tone as fair, and denies sensitive or abnormal skin conditions.She has previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) years ago and not recently.She has not previously experienced a problem/symptom with one of these products.The patient had one layer of clothing over the heatwrap and a cloth underneath the heatwrap, between the wrap and her skin.She was not wearing a snug waistband/belt or similar or otherwise applied pressure over the area, was not sleeping while wearing the wrap, did not engage in exercise while using the product, and was not taking any medications during the time the problem/symptom was experienced.The patient did check skin under the product while wearing thermacare and did read the usage instructions on thermacare before using the product.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2018.The outcome of the events was not recovered.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "burn blisters","blister has broken", "get hotter and hotter and then finally, it was so hot" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device ineffective" is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "burn blisters","blister has broken", "get hotter and hotter and then finally, it was so hot" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device ineffective" is non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] blister/burned/blister has broken [burns second degree] , get hotter and hotter and then finally, it was so hot [device issue] , still having a lot of pain [device ineffective] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 65-year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain, device lot number t65617, expiration date sep2020), via an unspecified route of administration on (b)(6) 2018 for pulled muscle in upper thigh.There are no concomitant products, medical conditions or test results to report at this time.The patient has used thermacare in the past and has not experienced problem/symptom during previous use.The patient recently purchased a 3 pack of smaller wraps to use for a pulled muscle in her upper thigh.The one was super-hot, and the others were not.At first, she applied the heatwrap to her body.When it started to get hot, she put cloth between her skin and the actual heat wrap so that it wouldn't get super-hot and it still remained to get hotter and hotter and then finally, it was so hot that she took it off and that is when she saw the blister to left upper thigh.The heatwrap burned her and she literally got a huge blister on 11may2018.The patient had used the heatwrap between 6-8 hours, put on in the morning and took off in the afternoon.The patient states the blister has broken, was still open on 11may2018 and hasn't healed.She was still having a lot of pain on 11may2018 from the pulled muscle in her upper thigh, but will not put a heatwrap on it now.She cleaned off the blister with hydrogen peroxide, put antibiotic cream on it and has the blister covered to make sure there was no infection.The patient stated she used another heatwrap far below the area of blister because of the cramping/her muscle problem so it wouldn't affect the blister in any way.She found the next two heatwraps were hardly even hot.Patient classified skin tone as fair, and denies sensitive or abnormal skin conditions.She has previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) years ago and not recently.She has not previously experienced a problem/symptom with one of these products.The patient had one layer of clothing over the heatwrap and a cloth underneath the heatwrap, between the wrap and her skin.She was not wearing a snug waistband/belt or similar or otherwise applied pressure over the area, was not sleeping while wearing the wrap, did not engage in exercise while using the product, and was not taking any medications during the time the problem/symptom was experienced.The patient did check skin under the product while wearing thermacare and did read the usage instructions on thermacare before using the product.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2018.The outcome of the events was not recovered.Device was available for evaluation.According to the product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).Evaluation of the return sample did not show any obvious defects to the wraps.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports a wrap "burned her, and she literally got a huge blister.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.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.Process related?: no.Complaint confirmed?: no.Design related?: no.Notify safety?: no.Additional information has been requested and will be provided as it becomes available.Follow-up (b)(6) 2018): new information received from the product quality complaint group included investigational results.Company clinical evaluation comment based on the information provided, the events of burns second degree and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective is non-serious.The 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 events of burns second degree and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective is non-serious.The 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.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).Evaluation of the return sample did not show any obvious defects to the wraps.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports a wrap "burned her, and she literally got a huge blister.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.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.Process related?: no.Complaint confirmed?: no.Design related?: no.Notify safety?: no.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 7560424
• MDR Text Key: 109886118
• Report Number: 1066015-2018-00074
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2020
• Device Lot Number: T65617
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 56